MAUDE Adverse Event Report: EXACTECH, INC. TRUL FEM IMPACTOR HEAD LOCKING; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRUL FEM IMPACTOR HEAD LOCKING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2021
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, during an initial procedure, the surgeon was using the truliant femoral locking clamp impactor to implant the patient¿s femur.While impacting the claw on the locking mechanism broke off.The surgeon used the secondary femoral impactor to finish impacting/implanting the femur.The broken instrument was handed off the sterile field and will be returned.The patient left the or stable.There was no delay to the surgery.Patient was last known to be in stable condition following the event.The facility did not provide specific patient information.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2 and h3 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of the femoral impactor experiencing impaction forces likely during surgical use which led to crack initiation, propagation, and ultimate failure of the threaded rod subcomponent.The most probable root cause associated with the report event, the problem associated with a partial or full-thickness crack in the device materials.

• Brand Name: TRUL FEM IMPACTOR HEAD LOCKING
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11271910
• Report Number: 1038671-2021-00025
• Device Sequence Number: 3477156
• Product Code: JWH
• UDI-Device Identifier: 10885862523587
• UDI-Public: 10885862523587
• Combination Product (Y/N): N
• 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): 02/23/2021

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: TRUL FEM IMPACTOR HEAD LOCKING
• Device Catalogue Number: 02-029-19-1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1