MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC {} P/S CAM MODULE SZ 6; PRSTHSIS,KNEE,PATLL,SMI-CONSTRIND, UNCMNTD, PROUS COATD, PLYMR/MTL/PLYMR

Model Number	71433366
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument broke during impacting.A backup device was available to complete the procedure.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality 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.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.Based on this investigation, the need for corrective action is not indicated.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII SPC {} P/S CAM MODULE SZ 6
• Common Device Name: PRSTHSIS,KNEE,PATLL,SMI-CONSTRIND, UNCMNTD, PROUS COATD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9774193
• Report Number: 1020279-2020-00751
• Device Sequence Number: 19224467
• Product Code: MBH
• UDI-Device Identifier: 00885556032015
• UDI-Public: 00885556032015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: No Information
• Device Model Number: 71433366
• Device Catalogue Number: 71433366
• Device Lot Number: 11HM17437A
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 07/30/2020
• Patient Sequence Number: 1