MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II FEMORAL TRIAL IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71440468
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during office inspection, it was found that the tensioner flange on the genesis ii femoral trial impactor has broken off.No case involved; therefore, there was no patient involvement.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection was performed and confirmed the trial impactor is broken, missing a pin and head.Burrs and gouges on the device indicate signs of excessive wear.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.Based on this investigation, the need for corrective action is not indicated.Should 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: GNS II FEMORAL TRIAL IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11794938
• Report Number: 1020279-2021-03891
• Device Sequence Number: 11726173
• Product Code: LXH
• UDI-Device Identifier: 03596010215642
• UDI-Public: 03596010215642
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/24/2021

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 Expiration Date: 05/07/2015
• Device Model Number: 71440468
• Device Catalogue Number: 71440468
• Device Lot Number: 05AM17232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1