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Based on observation, interview, and record review, the hospital failed to provide surgical services in accordance with acceptable standards of practice when the manufacturer's instructions for use (IFU) was not followed for Patient (Pt) 1and Pt 1 had to undergo a second procedure to remove a retained foreign object (any surgical instrument, tool, device, or sponge unintentionally left inside a patient's body after a surgical procedure). (Refer to A-0951)

The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

Based on interview and record review the hospital failed to ensure patient's rights to make informed decisions about care when the informed consent (a document that shows the surgeon discussed the surgery with the patient and the patient understands what will occur and the risks and benefits of the surgery) was not obtained for one of 20 sampled patients (Pt 1) according to the hospital's policy and procedure (P&P) titled, "Consents, Operative and Procedural."

This failure denied Pt 1 of her right to consent to decisions about her care.

Findings:

During a review of Pt 1's "History and Physical (H&P-a formal assessment of a patient's health that includes a medical history and physical exam)," dated 1/9/25, the "H&P" indicated Pt 1 was a 67-year-old female admitted to the hospital on 1/10/25 for a right total knee arthroplasty (a surgical procedure that involves replacing the damaged surfaces of the knee joint with artificial components) using robotic assistance (advanced technology to help the orthopedic surgeon perform knee replacement). Pt 1 had a diagnosis of complex tear of the lateral (the outer side) and medial (inner side) meniscus (a crescent-shaped fibrous cartilage between the bones at the knee) to the right knee and unilateral primary osteoarthritis of the right knee. Pt 1 had a past medical history of hypertension (high blood pressure) and right breast cancer.

During a review of Pt 1's "Operative Report," dated 1/10/25, the "Operative Report" indicated, " ... PREOPERATIVE DIAGNOSIS: Foreign body, right knee ... PROCEDURE PERFORMED: Right knee irrigation, debridement (a medical procedure that involves removing dead, damaged, or infected tissue from a wound), removal of foreign body, polyethylene (a type of plastic) exchange ... ANESTHESIA: General ... PROCEDURE INDICATION: The patient is a patient who had a right total knee arthroplasty January 10, 2025, which was earlier today. [Pt 1] did well with surgery. She was brought to the PACU area and got her standard 2-view x-rays. Upon reviewing the 2-view x-rays, there was a radiodense (the relative inability of X-rays or radio waves to pass through a material, causing it to appear white or light-colored on a radiograph or image) material in the posterolateral (situated on the side and toward the back of the body) aspect of the knee. Revision x-rays were taken, taking off all dressings to ensure that there was nothing that could be making this superficially. When going back to the trays for the trials of polyethylene, it was noted that the spring for the size 7 polyethylene was missing. This matched the radiodensity that was seen in the x-ray. This was discussed with the patient and the patient's husband at bedside. Decision was made to go back and do a removal of foreign body ..."

During a concurrent interview and record review on 3/13/25 at 2:25 p.m. the Director of Quality (DQ) and Registered Nurse (RN) 1, Pt 1's electronic health record (EHR-a digital version of a patient's medical history) was reviewed. RN 1 was unable to locate the informed consent form in Pt 1's EHR for the second procedure performed on Pt 1 to remove the retained foreign object (object unintentionally left inside a persons body).

During an interview on 3/14/25 at 10:33 a.m. with the Interim Chief Nursing Officer (ICNO), the ICNO stated Pt 1 did not have an informed consent form completed and signed for the second procedure to remove the retained foreign body.

During a review of the facility's P&P titled, "Consents, Operative and Procedural," dated 8/21/19, the P&P indicated, " ... PURPOSE: To protect the patient against unauthorized procedures being performed. To ensure that patients have been provided with appropriate information to make informed decisions ... PROCEDURE: 1. Consent to Surgery or Special Procedure Form: a. All consent forms will include the following information: planned procedure, as ordered by the physician; name of the surgeon(s); name of the patient ... c. If a procedure is to be added or removed from the consent or the consent has the wrong procedure, wrong laterality, etc., the patient/patient's legal representative and a licensed nurse will sign a new consent with the correct procedure ... 3. Obtaining Consent: a. Patient/patient's legal representative will read the consent form. b. Patient/patient's legal representative will be asked to sign the consent form. If the patient/patient's legal representative consents to the treatment, a licensed nurse will witness the patient/patient's legal representative signature on the consent and sign on the consent form ... 5. Documentation a. Obtain the signature of the patient/patient's legal representative along with the date and time. b. Witnesses ... Licensed nurses and may act as a witness to consent forms ... Witnesses must be present when the form is signed by the patient/patient's legal representative ... c. Original consent will be placed in the medical record. d. Provide the patient/patient's legal representative with a copy of the consent. 6. procedures requiring additional consent: Any additional circumstances other than the surgical procedure require patient consent in order to assure patient knowledge of such. a. Any invasive procedures performed after initial procedure would require an additional consent ..."

Based on observation, interview and document review, the hospital Quality Assurance and Performance Improvement (QAPI) program failed to adequately investigate and analyze the cause of a retained foreign object (any surgical instrument, tool, device, or sponge unintentionally left inside a patient's body after a surgical procedure) related to Patient (Pt) 1's total knee replacement when the QAPI program was unaware of a 2015 published Safety Alert for the coil/spring of the trial device placed into Pt 1 which was identified as the retained foreign object.

This failure resulted in the hospital not benefiting from utilizing Safety Alert publications in their investigations and analyses for surgical adverse events and possibly not implementing effective interventions and actions to prevent adverse events.

Findings:

During a review of the hospital's "report to [California Department of Public Health]" dated 1/15/25, the report indicated, " ... Event Details-1/10/25 [at 2:05 p.m.] post [operation] x-ray noted that a small round coil used during [Medical Doctor (MD) 1's] second case remained in the wound. [MD 1] was trialing different poly liner (also called a trial insert) prior to opening up final implants (the implant that is permanently retained by the patient). During the trialing process, one of the liner trials fell on the ground. Because of this, the back-up set was opened to build a liner trial (tray). The original set opened were all solid liner trials that came in one piece. However, the backup set that was available comes in two pieces, to be able to build whichever size liner trial needed. The liner trial was built and placed in the knee to trial. During the process of removing that liner trial from the knee, a spring on the bottom of one of the instruments became detached and remained in the wound ..."

During a concurrent observation and interview on 3/11/25 at 11:05 a.m. with the Director of Surgical Services (DSS), of the actual liner trial used during the first surgery, the liner trial was noted to have two pegs on the underside of the device. One peg had a small, coiled spring around it, approximately 1/4 inch outside diameter. The second peg did not have a spring attached. We observed the second spring, which was in a specimen cup. The DSS stated this was the spring that was retained (left in the patient accidentally) and was removed by Medical Doctor (MD) 1 later the same day in a second surgery. The DSS stated the liner trial that is normally used does not have these springs, and the Scrub Technician (ST - the person who gives the surgical instruments to the surgeon) was not familiar with the model with the springs, and neither was the surgeon. The DSS stated that during their Root Cause Analysis on 1/23/25 (RCA - a systematic process used to identify the underlying causes of a problem, rather than just addressing the symptoms, to prevent recurrence and improve processes) they were unable to find any other cases where the springs have come off during surgery or any previous concerns with the liner trial device.

During an interview on 3/11/25 at 12:20 with Medical Doctor (MD) 1, MD 1 stated that when the second insert trial was handed to him, he was aware that the device "looked a little different" but did not notice the little springs that could potentially come off. MD 1 stated the original was dropped, which was why he had to go with the back-up device. MD 1 stated this was not the actual implant, it was the sizing mechanism, used to make sure the actual knee implant was the correct size for the patient. MD 1 stated he always gets an x-ray after his surgeries, and this is how they identified that the spring was left inside Pt 1's knee. MD 1 stated he went to talk with the patient and spouse immediately and explained what had happened and that they needed to return to surgery to remove something that shouldn't be there.

During a review of a document titled, "URGENT FIELD SAFETY NOTICE" retrieved on 3/11/25 from https://www.hsa.gov.sg/docs/default-source/announcements/field-safety-notices/hsa-6004101-002-15-25_16-fsn.pdf on 3/11/25 at 1:30 p.m., the document indicated, " ... The Field Safety Notice is being issued due to the potential for the [brand name], which is a small wire spring coil located on the post feature of the Articulation Surface Instruments (Figure 1), to become damaged and disassociate (come off). The [brand name] is constructed from implant grade stainless steel. If the [brand name] is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation ..."


During a review of a document retrieved on 3/11/25 from https://www.jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2021-03/ATTUNE%20Cementless%20RP%20Surgical%20Technique%20152619-200910.pdf titled SURGICAL TECHNIQUE FEATURING THE (brand name of knee implant,) the document, distributed by the manufacturer, indicated, " ...This surgical technique provides guidelines for the implantation of the [brand name] Instrumentation ...Trial Components ... Check for [brand name] spring damage. If damage is observed, replace the damaged component."

During a concurrent interview and document review on 3/11/25 at 2:30, with the DSS and the Manager of Perioperative (during surgery) Services (MPS) 1 the "URGENT FIELD SAFETY NOTICE" dated 6/19/15, was reviewed. The DSS stated, "I'm shocked. We are both shocked to see this." The DSS stated she was not aware that there was a safety notice on the trial insert used for Pt 1. The MPS stated she has worked in this hospital for 28 years and she was not aware of this "URGENT FIELD SAFETY NOTICE." MPS stated she is not aware of any urgent safety notices on other devices, but "now I wonder if there are others that we aren't aware of."

During an interview on 3/13/25 at 9:00 a.m. with Scrub Tech (ST) 1 and Registered Nurse (RN) 2, ST 1 stated he was aware that the back up trial insert was a little different, but he wasn't aware that there were springs that could come off. ST 1 stated the spring coils are so tiny that you can't really see them, and he thought it was one solid component. ST 1 and RN 2 stated they were not aware that there was a safety notice in place regarding this trial insert, or any other devices they use in the surgical area. ST 1 stated, "How would I know if there was a safety issue with a device? Shouldn't the vendor or the hospital be sharing this information with us?" RN 2 stated they weren't aware that the spring had been left inside the patient until they were doing the next surgery and MD 1 said they were bringing Pt 1 back to the OR because the x-ray showed a "foreign object" in the knee. ST 1 and RN 2 stated they attended the RCA investigation for this incident, and there was no discussion about the device being a safety risk. RN 2 stated if the information had been available about the safety alert, "It probably would have been a different discussion. The focus would have been different."

During an interview on 3/13/25 at 11:10 with the Director of Materials Management (DMM), the DMM stated information regarding recalled equipment and safety alerts come through his office. DMM stated they have a good process for managing recalled equipment, but it is hard to identify equipment that has a safety alert, because they are in the same database as the recalls. DMM stated he cannot produce a list of surgical devices that have safety alerts.

During an interview on 3/13/24 at 2:30 with the Interim Chief Nursing Officer (ICNO) and the DSS, the DSS stated she was the coordinator of the RCA on 1/23/25. The DSS stated the RCA did not include that there was a safety alert for the device or that the manufacturer's instructions included a warning about the coils being at risk of damage and the need for close inspection, because she wasn't aware of this. The DSS stated the template used to do the RCA did not include doing research to determine if the error had occurred at other facilities or to determine if any safety alerts had been issued regarding the device, and she followed the template. The RCA did not include the need to keep track of instruments and devices with a safety alert or to educate staff on precautions needed if an instrument or device has a safety alert.

During an interview on 3/14/25 at 10:18 a.m., the ICNO stated the scrub technician role is the final quality inspection of any instrument prior to handing the instrument to the surgeon. The ICNO stated ST 1 should have been familiar with the trial insert and should have been aware that it could come apart so that he could alert the surgeon. The ICNO stated the RCA in this event was not comprehensive, and more research should have been done before the RCA so the team could have had information about the safety alert prior to the discussion of root causes for the error.

During a review of hospital policy titled, "Patient Safety & Performance Improvement Plan 2025 Annual Evaluation," dated 8/22/24, the document indicated, "PURPOSE: The Patient Safety and Performance Improvement Plan establishes guidelines and processes supporting a comprehensive, effective, organization-wide patient safety program designed to improve patient safety by preventing medical/healthcare errors, injuries, and reducing risks of hospital-acquired conditions (HAC) to patients. The Plan will be evaluated annually on the following elements: Purpose, Scope, Goals and Objectives, and Performance and Effectiveness ... GOALS AND OBJECTIVES ... Support a data collection system to monitor performance improvements of new or revised processes and potential risks throughout the facility.."

Based on interview and record review, the hospital failed to ensure nursing administered medications in accordance with the physician's order and hospital's policy and procedure (P&P) when Patient (Pt) 19 was given one tablet of oxycodone (a narcotic pain medication)-acetaminophen (a mild pain medication) for pain levels of 5/10 (on a scale of 0-10 with 0 being no pain and 10 being the worse pain), when the order was for 2 tablets of oxycodone-acetaminophen for a pain level of 5/10 to 10/10.

This failure resulted in Pt 19 not having adequate pain relief and still reported pain after pain medication was given.

Findings:

During a review of Pt 19's "History and Physical (H&P-a formal assessment of a patient's health that includes a medical history and physical exam)," dated 3/3/25, the "H&P" indicated Pt 19 was admitted to the hospital for a transformational lumbar interbody fusion (TLIF-a surgical procedure used to treat chronic back pain and spinal instability in the lower lumbar spine) from L2 to L5 (the lower vertebrae of the lumbar spine). Pt 19's diagnosis included spinal stenosis (when the space inside the backbone is too small), radiculopathy (injury or damage to nerve roots in the area where they leave the spine), and spondylosis (spondylosis) to the lumbar (the lower part of the spinal column) regions and low back pain.

During a concurrent interview and record review on 3/12/25 at 11:30 a.m. with the Director of Inpatient Services (DIS) and Registered Nurse (RN) 1, Pt 19's "Medication Order (MO)," dated 3/5/25 and "Medication Administration Record (MAR-an electronic record of medications that were given)," dated 3/7/25 to 3/8/25 were reviewed. The "MO" indicated, Pt 1's pain order was oxycodone/acetaminophen 5 milligrams (mg-unit of measure)/325 mg by mouth every 4 hours as needed for mild pain 1-4 give 1 tablet by mouth and moderate to severe pain (5-10) give 2 tablets by mouth. The "MAR" on 3/7/25 at 7:40 p.m. indicated Pt 19 reported a pain level of 5/10 and she was given one tablet of oxycodone-acetaminophen. The "MAR" on 3/7/25 at 8:40 p.m. indicated Pt 19 reported a pain level of 3/10 after being given the one tablet of oxycodone-acetaminophen. The "MAR" on 3/8/25 at 5:17 a.m. indicated Pt 19 reported a pain level of 5/10 and was given one tablet of oxycodone-acetaminophen. The "MAR" on 3/8/25 at 6:17 a.m. indicated Pt 19 reported a pain level of 2/10 after being given the one tablet of oxycodone-acetaminophen. RN 1 stated the medication order was to give two tablets for a pain level of 5/10 to 10/10. RN 1 stated Pt 19 should have been given the two tablets instead because Pt 19 still reported pain after. The DIS stated the nurse did not follow the order for pain management.

During an interview on 3/13/25 at 11:05 a.m. with the DIS, the DIS stated she expected nurses to follow the physician's order for pain management. The DIS stated nurses should follow the parameters in the pain management order.

During an interview on 3/14/25 at 10:18 a.m. with the Interim Chief Nursing Officer (ICNO), the ICNO stated she expected nurses to follow the parameters on the physician's order for pain management. The ICNO stated nurses should follow the physician's order as it is written. The ICNO stated nurses should contact the physician for clarification on orders or modifications to an order were needed.

During a review of the hospital's policy and procedure (P&P) titled, "Medication Orders," dated 8/21/24, the P&P indicated, " ... PURPOSE: To provide guidelines for the documentation of medication orders and administration of medication per those orders ... PROCEDURE: ... 5. Range Orders ... When a medication order includes a range of dose and/or frequency, clear instructions about how the nurse determines what dose to administer or the time frame in which to administer it must be clear in the order ... Pain Assessment: The nurse will assess a patient's pain by using the Wong-Baker Scale/Visual Analog Scale to determine pain severity. The following pain scale will apply: ... Mild 1-4 ... Moderate 5-7 ... Severe 8-10 ... Specific to PRN PO pain medication: ln order to protect and uphold patient's rights, improve response time to treatment of pain, and reduce the risk of adverse outcomes from over sedation, the patient may refuse the full dose (ex: 2 tablets and receive 1 tablet) of a medication indicated by the pain scale or ordered pain protocol ..."

During a review of the hospital's P&P titled, "Pain Management," dated 2/26/24, the P&P indicated, " ... PURPOSE: A- To recognize the patient's right to pain relief and support a multidisciplinary approach to pain assessment and management. B. To provide guidelines for: the recognition and ongoing assessment of pain and its appropriate management consistent with the patient's age, condition, and ability to understand. C. To establish standards for hospital staff and Licensed lndependent Practitioners (LlPs) for the assessment and management of pain ... POLICY: ... The patient's self-report of pain is the best measurement tool to use when assessing pain ..."

Based on observation, interview and record review, the hospital failed to implement interventions meant to support the effectiveness of the manufacturer's instructions for use (IFU) for one of one patients (Patient 1). On 1/10/25, during a surgical procedure for Patient (Pt) 1's right total knee arthroplasty (a surgical procedure that involves replacing the damaged surfaces of the knee joint with artificial components) a retained foreign object (any surgical instrument, tool, device, or sponge unintentionally left inside a patient's body after a surgical procedure) was identified in Pt 1 post operation.

This failure resulted in an unnecessary second procedure for Pt 1 and had the potential for Pt 1 to have an increased risk for infection, additional pain, and additional scarring.

Findings:

During a review of the hospital's "report to [California Department of Public Health]" dated 1/15/25, the report indicated, " ... Event Details-1/10/25 [at 2:05 p.m.] post [operation] x-ray noted that a small round coil used during [Medical Doctor (MD) 1's] second case remained in the wound. [MD 1] was trialing different poly liner (also called a trial insert) prior to opening up final implants (the implant that is permanently retained by the patient). During the trialing process, one of the liner trials fell on the ground. Because of this, the back-up set was opened to build a liner trial (tray). The original set opened were all solid liner trials that came in one piece. However, the backup set that was available comes in two pieces, to be able to build whichever size liner trial needed. The liner trial was built and placed in the knee to trial. During the process of removing that liner trial from the knee, a spring on the bottom of one of the instruments became detached and remained in the wound ..."

During a review of Pt 1's "History and Physical (H&P-a formal assessment of a patient's health that includes a medical history and physical exam)," dated 1/9/25, the "H&P" indicated Pt 1 was a 67-yar-old female admitted to the hospital on 1/10/25 for a right total knee arthroplasty (a surgical procedure that involves replacing the damaged surfaces of the knee joint with artificial components) using robotic assistance (advanced technology to help the orthopedic surgeon perform knee replacement). Pt 1 had a diagnosis of complex tear of the lateral (the outer side) and medial (inner side) meniscus (a crescent-shaped fibrous cartilage between the bones at the knee) to the right knee and unilateral primary osteoarthritis (degenerative joint condition affecting only one side of the body) of the right knee. Pt 1 had a past medical history of hypertension (high blood pressure) and right breast cancer.


During a concurrent observation and interview on 3/11/25 at 11:05 a.m. with the Director of Surgical Services (DSS,) the actual liner trial used during the first surgery, the liner trial was noted to have two pegs on the underside of the device. The DSS stated one peg had a small, coiled spring around, the outside diameter approximately a quarter of an inch. The second peg did not have a spring attached. A second spring was observed in a specimen cup. The DSS stated this was the spring that was retained (left in the patient accidentally) and was removed by MD 1 later the same day in a second surgery. The DSS stated the liner trial that is normally used does not have these springs, and the Scrub Technician (ST - the person who gives the surgical instruments to the surgeon) was not familiar with the model with the springs, and neither was the surgeon. The DSS stated that during their Root Cause Analysis on 1/23/25 (RCA - a systematic process used to identify the underlying causes of a problem, rather than just addressing the symptoms, to prevent recurrence and improve processes) they were unable to find any other cases where the springs have come off during surgery or any previous concerns with the liner trial device.

During an interview 3/11/25 at 12:20 p.m. with Medical Doctor (MD) 1, MD 1 stated that when the second insert trial was handed to him, he was aware that the device "looked a little different" but did not notice the little springs that could potentially come off. MD 1 stated the original was dropped, which was why he had to go with the back-up device. MD 1 stated this was not the actual implant, it was the sizing mechanism, used to make sure the actual knee implant was the correct size for the patient. MD 1 stated he always gets an x-ray after his surgeries, and this was how they identified that the spring was left inside Pt 1's knee. MD 1 stated he went to talk with the patient and spouse immediately and explained what had happened during the surgery, and that they needed to return to surgery to have it removed.

During a review of Pt 1's "Operative Report," dated 1/10/25, the "Operative Report" indicated, " ... PREOPERATIVE (before the surgery) DIAGNOSIS: Foreign body, right knee ... PROCEDURE PERFORMED: Right knee irrigation (flushing a wound or surgical site), debridement (a medical procedure that involves removing dead, damaged, or infected tissue from a wound), removal of foreign body, polyethylene (a type of plastic) exchange ... ANESTHESIA General (a temporary loss of feeling and a complete loss of awareness): ... PROCEDURE INDICATION: The patient is a patient who had a right total knee arthroplasty January 10, 2025, which was earlier today. [Pt 1] did well with surgery. She was brought to the PACU (Post-Anesthesia Care Unit where patients are closely monitored after surgery) area and got her standard 2-view x-rays. Upon reviewing the 2-view x-rays, there was a radiodense (the relative inability of X-rays or radio waves to pass through a material, causing it to appear white or light-colored on a radiograph or image) material in the posterolateral (situated on the side and toward the back of the body) aspect of the knee. Revision (repeating) x-rays were taken, taking off all dressings to ensure that there was nothing that could be making this superficially. When going back to the trays for the trials of polyethylene, it was noted that the spring for the size 7 polyethylene was missing. This matched the radiodensity that was seen in the x-ray. This was discussed with the patient and the patient's husband at bedside. Decision was made to go back and do a removal of foreign body ..."

During a review of a document titled, "URGENT FIELD SAFETY NOTICE" retrieved on 3/11/25 from https://www.hsa.gov.sg/docs/default-source/announcements/field-safety-notices/hsa-6004101-002-15-25_16-fsn.pdf on 3/11/25 at 1:30 p.m., the document indicated, " ... The Field Safety Notice is being issued due to the potential for the [brand name], which is a small wire spring coil located on the post feature of the Articulation Surface Instruments (Figure 1), to become damaged and disassociate (come off). The [brand name] is constructed from implant grade stainless steel. If the [brand name] is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation ..."

During a review of a document retrieved on 3/11/25 from https://www.jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2021-03/ATTUNE%20Cementless%20RP%20Surgical%20Technique%20152619-200910.pdf titled SURGICAL TECHNIQUE FEATURING THE (brand name of knee implant,) the document, distributed by the manufacturer, indicated, " ...This surgical technique provides guidelines for the implantation of the (brand name) Instrumentation ...Trial Components ... Check for (brand name) spring damage. If damage is observed, replace the damaged component."

During a concurrent interview and document review on 3/11/25 at 2:30, with the DSS and the Manager of Perioperative (during surgery) Services (MPS) 1 the "URGENT FIELD SAFETY NOTICE" dated 6/19/15, was reviewed. The DSS stated, "I'm shocked. We are both shocked to see this." The DSS stated she was not aware that there was a safety notice on the trial insert used for Pt 1. The MPS stated she has worked in this hospital for 28 years and she was not aware of this "URGENT FIELD SAFETY NOTICE." MPS stated she is not aware of any urgent safety notices on other devices, but "now I wonder if there are others that we aren't aware of."

During an interview on 3/13/25 at 9:00 a.m. with Scrub Tech (ST) 1 and Registered Nurse (RN) 2, ST 1 stated he was aware that the back up trial insert used for Pt 1 was a little different, but he wasn't aware that there were springs that could come off. ST 1 stated the spring coils are so tiny that you can't really see them, and he thought it was one solid component. ST 1 and RN 2 stated they were not aware that there was a safety notice in place regarding this trial insert, or any other devices they use in the surgical area. ST 1 stated, "How would I know if there was a safety issue with a device? Shouldn't the vendor or the hospital be sharing this information with us?" RN 2 stated they weren't aware that the spring had been left inside the patient until they were doing the next surgery and MD 1 said they were bringing Pt 1 back to the OR because the x-ray showed a "foreign object" in the knee. ST 1 and RN 2 stated they attended the RCA investigation for this incident, and there was no discussion about the device being a safety risk. RN 2 stated if the information had been available about the safety alert, "It probably would have been a different discussion. The focus would have been different."

During an interview on 3/14/25 at 10:18 a.m. with the Interim Chief Nursing Officer (ICNO), the ICNO stated the scrub technician role was the final quality inspection of any instrument prior to handing the instrument to the surgeon. The ICNO stated ST 1 should have been familiar with the trial insert and should have been aware that it could come apart so that he could alert the surgeon. The ICNO stated the RCA in this event was not comprehensive, and more research should have been done. The ICNO stated if more information would have been presented before the RCA the team could have had information about the safety alert prior to the discussion of root causes for the error.

During a review of the facility's document titled, "Operating Room (OR) Technician," undated, the document indicated, " ... Job Summary: Assists surgeon during operative and invasive procedures (medical procedure that enters the body usually by cutting the skin or inserting instruments into the body). Ensures operating suite is adequately prepared for procedure. Monitors PAR [Periodic Automatic Replenishment-set minimum and maximum quantities of a specific instrument a location should have on hand to ensure adequate supply and prevent shortages or overstocking] level of all surgical instruments and supplies ... Essential Functions: Check all equipment for proper functioning ... Makes decisions reflecting knowledge of assigned case and instruments and/or trays to be pulled for the procedure ..."


During a review of the manufacturer's IFU, undated, the IFU indicated, " ... The instruments used to implant orthopaedic prostheses (artificial body part that replaces a part that is no longer functional) do not have an indefinite function life. All reusable instruments are subjected to repeated stresses related to bone contact, impaction and routing, cleaning and sterilization (any process that destroys or eliminates germs) process. It is essential that the surgeon and operating theatre staff are fully conversant with the appropriate surgical technique for the instruments and associated implant, if any ... A. Warnings ... Ensure that no instruments or pieces of instruments are left in the surgical site prior to closure, as they may not be detectable using imaging techniques such as X-ray or MRI (Magnetic Resonance Imaging scan that produces three dimensional detailed images of the body) and patient injury may result ... B. Limitations on Reprocessing (process for cleaning, reconditioning, testing and disinfection) ... Carefully inspect devices between uses to verify proper function ... O. Maintenance ... Carefully inspect instruments between uses to verify proper functioning ... P. Inspection and Functional Testing ... [Brand name] devices should be inspected after processing prior to sterilization for: Cleanliness; Damage, including but not limited to, corrosion (rust, pitting) discoloration, excessive scratches, flaking, cracks, and wear; Proper function, including but not limited to cutting tools should be sharp and free from nicks, long thin instruments should be checked for bending and distortion, movement of hinges/joints/box locks and moveable features such as handles, ratchets and couplings, jaws and teeth should align properly and locking mechanisms should fasten ..."