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

Model Number	FEMORAL LOCKING IMPACTOR ENZTEC DESIGN
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, while impacting the trial ps femur, the distal tip of the locking arm broke off.This prevented the locking arms from being able to hold on to the femoral component.The broken piece was located on the bed and discarded.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
(h1) this report was submitted in error as this is a distributed product.The product distributor has been notified.Please disregard this submission.

• Brand Name: FEMORAL LOCKING IMPACTOR ENZTEC DESIGN
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11422316
• Report Number: 1038671-2021-00093
• Device Sequence Number: 3764188
• Product Code: JWH
• UDI-Device Identifier: 10885862577917
• UDI-Public: 10885862577917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/15/2021

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: FEMORAL LOCKING IMPACTOR ENZTEC DESIGN
• Device Catalogue Number: 02-029-19-1300
• Device Lot Number: UNKNOWN
• 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: 03/15/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1