MAUDE Adverse Event Report: EXACTECH, INC. TRUL FEM IMPACTOR HEAD LOCKING; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	02-029-19-1000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee procedure, while impacting the final femoral implant, the impactor broke.There was a slight surgical delay while loading a secondary impactor.The patient did not experience an adverse event due to the delay.The patient was last known to be in stable condition following the event.The device is available for return.A device image was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d, f, g, the fracture and deformation reported was likely the result of the surgeon impacting the femoral impactor head directly in the medial/lateral direction, which imposed high loads to the threaded shaft and led to crack initiation, propagation, and ultimate fracture of the threaded shaft.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRUL FEM IMPACTOR HEAD LOCKING
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20018747
• Report Number: 1038671-2024-02960
• Device Sequence Number: 7476713
• Product Code: MBH
• UDI-Device Identifier: 10885862523587
• UDI-Public: 10885862523587
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/23/2025

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 Catalogue Number: 02-029-19-1000
• Device Lot Number: 117574003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/23/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male