MAUDE Adverse Event Report: EXACTECH, INC. LOCKING FEMORAL IMPACTOR 0-5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	LOCKING FEMORAL IMPACTOR 0-5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during impaction, the head of the femoral impactor is fractured.There were no parts or pieces of the device fell into the patient wound site.There was no surgical delay/prolongation.The device will not be returned as it was disposed by the hospital.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) based on similar previous complaint investigations and the picture of the device, the fractured impactor face reported was likely the result of material degradation associated with years of surgical use and subsequent sterilization cycles.The most probable root cause associated with the reported event of "fracture" is associated with a partial or full-thickness crack in the device materials.

• Brand Name: LOCKING FEMORAL IMPACTOR 0-5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13061424
• Report Number: 1038671-2021-00729
• Device Sequence Number: 16546473
• Product Code: LXH
• UDI-Device Identifier: 10885862059833
• UDI-Public: 10885862059833
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: LOCKING FEMORAL IMPACTOR 0-5
• Device Catalogue Number: 213-64-01
• Device Lot Number: 103085001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown