MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	TRULIANT CC FEM TRIAL SIZE 3
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
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
It was reported that during a difficult primary knee, while trialing with a size 3 cc logic femoral component, during impaction, the trial suffered from metal fatigue.It was impacted onto the distal femur and the posterior condyle portion of the trial snapped.No parts or pieced fell into the wound site.The surgeon used the logic size 3 femoral trial to continue the operation and trialing.There was a 5-15 minute surgical delay with no adverse effect to the patient.The patient was last known to be in stable condition following the event.The device is available for return.
Additional Manufacturer Narrative
H6: the broken instrument reported was likely the result of applying excess force to the femoral trial during impaction.However, this cannot be confirmed as the device was not available for evaluation.

• Brand Name: TRULIANT
• 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
• MDR Report Key: 16588192
• Report Number: 1038671-2023-00478
• Device Sequence Number: 6138400
• Product Code: LXH
• UDI-Device Identifier: 10885862521934
• UDI-Public: 10885862521934
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2026

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: TRULIANT CC FEM TRIAL SIZE 3
• Device Catalogue Number: 02-011-06-1130
• Device Lot Number: 81659003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 05/13/2026
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/15/2023; 06/04/2026
• 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: Required Intervention; Other
• Patient Sex: Female