MAUDE Adverse Event Report: EXACTECH, INC. ANKLE TIBIAL CENTER PUNCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	351-10-26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
During surgery, the surgeon asked for the center impaction instrument for the tibial implant on the vantage system.They impacted the tibia, but the bone was sclerotic, due to a previous fracture, so the surgeon impacted a second time and when they returned the instrument to the scrub practitioner it was noticed that the tip of the instrument had fractured off.The tip was removed from the tibia of the patient.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the broken center peg punch reported was likely the result of both high impaction forces and the patient¿s hard bone, which led to crack initiation, propagation, and ultimate fracture of the peg punch tip.

• Brand Name: ANKLE TIBIAL CENTER PUNCH
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16310773
• Report Number: 1038671-2023-00109
• Device Sequence Number: 12463313
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: 351-10-26
• Device Catalogue Number: 351-10-26
• Device Lot Number: 287617003
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/20/2023; 09/25/2026
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/03/2023; 09/30/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female