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

Model Number	00133602800
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The visual inspection of the device confirms that the femoral impactor white head is missing from the device.This piece was not returned with the device.The device shows significant signs of wear/usage.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur. expected wear/tear is likely the probable cause 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.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.
Event or Problem Description
It was reported that, during a tka surgery, a femoral impactor was scarred/damaged.This happened before use in patient.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.Investigation shows that the femoral impactor white head is missing from the device due to fracture.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: FEMORAL IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12584597
• Report Number: 1020279-2021-07452
• Device Sequence Number: 16967181
• Product Code: LXH
• UDI-Device Identifier: 00885556618738
• UDI-Public: 00885556618738
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: 00133602800
• Device Catalogue Number: 00133602800
• Device Lot Number: 60139475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1