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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during impaction black plastic coating on the impaction handle chipped loose during impaction of the trial femur.Surgeon noticed right away and he checked the surgical site for debris.Confirmed clean and procedure carried on with no delay.There was no surgical delay/prolongation.Patient in stable condition.Sales rep was unable to obtain photos or x-rays.Product will be return.
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 historical complaint investigations and the returned device, the broken device reported was likely the result of years of surgical use and subsequent sterilization cycles, which resulted in a portion of the impaction face fracturing from the impactor body.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: 14823467
• Report Number: 1038671-2022-00717
• Device Sequence Number: 17296379
• Product Code: LXH
• UDI-Device Identifier: 10885862059833
• UDI-Public: 10885862059833
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 34534005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 08/23/2022
• 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