MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S1-2 9; TRAY, SURGICAL, INSTRUMENT

Model Number	71430401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a genesis ii total knee replacement, while removing the trial from the patient, the surgical assistant noticed that a piece of purple plastic was still in the patient.There appears to be two pieces of plastic missing, but only one piece was recovered from the patient.It is uncertain as to whether the poly was already damaged prior to use or if both pieces snapped off during this particular case.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that during a genesis ii total knee replacement a piece of the trial insert broke off inside the patient while it was being removed.The surgical assistant noticed that a piece of purple plastic was still in the patient.The insert appeared to have two pieces missing, but only one piece was recovered from the patient.It was also stated that it is unknown whether the insert was already damaged prior to use.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows the part is broken at the edges of the slot on both sides.One broken piece was returned.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A relationship between the device and the reported incident or adverse event is corroborated.A medical analysis noted that the surgeon washed out the patient using the pulse lavage, and the surgeon is happy that there is no retained product.There was no patient injury or surgical delay reported.Therefore, no further clinical assessment is warranted at this time.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.A review of the risk management files revealed that this failure mode has been identified.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Additional information: d4.

• Brand Name: GII PS HI FLEX ISRT TR S1-2 9
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11108720
• Report Number: 1020279-2021-00029
• Device Sequence Number: 3595788
• Product Code: FSM
• UDI-Device Identifier: 03596010493019
• UDI-Public: 03596010493019
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71430401
• Device Catalogue Number: 71430401
• Device Lot Number: 57022464
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention