MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420816
Medical Device Problem Codes	Defective Component (2292); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, after multiple attempts, the 3/4-9mm posterior stabilized articular insert would not lock.Procedure continued with a backup device from smith and nephew of the same size and with a delay greater than 30 minutes.
Additional Manufacturer Narrative
Results of investigation: the device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the stated failure.The locking detail of the device is damage from attempted insertion.The visual also confirms some scratches on the surface of the insert.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 3-4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11326148
• Report Number: 1020279-2021-01223
• Device Sequence Number: 16349578
• Product Code: JWH
• UDI-Device Identifier: 03596010209573
• UDI-Public: 03596010209573
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420816
• Device Catalogue Number: 71420816
• Device Lot Number: 19HM26440
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/05/2021; 07/15/2021
• Initial Report FDA Received Date: 02/14/2021
• Supplement Report FDA Received Date: 03/11/2021; 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65