MAUDE Adverse Event Report: EXACTECH, INC. LOCKING FEMORAL IMPACTOR 0-5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

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	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, when impacting the final femur, the plastic on the locking femoral impactor broke.This incident caused no delay, the patient was not affected, and the surgery outcome was great.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
H3: the evaluation noted that revision reported was likely the result of material degradation associated with years of normal use and subsequent sterilization cycles which led to fracture of the impaction face.The most likely root cause for the reported event of 'broken/non-functional" is associated with a partial or full-thickness crack in the device materials.

• Brand Name: LOCKING FEMORAL IMPACTOR 0-5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11417506
• Report Number: 1038671-2021-00092
• Device Sequence Number: 16989642
• Product Code: JWH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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 Model Number: LOCKING FEMORAL IMPACTOR 0-5
• Device Catalogue Number: 213-64-01
• Device Lot Number: 38132016
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1