MAUDE Adverse Event Report: EXACTECH, INC. ANKLE TIBIAL CENTER PUNCH; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	ANKLE TIBIAL CENTER PUNCH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during shipping/receiving, when the loaner kit returned to our warehouse, our team recognized the breakage of the device.During surgical use, hard sclerotic bone was detected in the young patient which led to the necessity of applying more force to the impactor.In conclusion, the force led to a breakage of the device.There was no no parts or pieces fell into the patient wound site and there was less than 5-minutes surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The product will be return.No other surgical information provided.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
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.The most probable root cause associated with the reported event of ¿broken / non-functional¿ is associated with a partial or full-thickness crack in the device materials.Section d4: lot number.

• Brand Name: ANKLE TIBIAL CENTER PUNCH
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17260412
• Report Number: 1038671-2023-01542
• Device Sequence Number: 17617050
• Product Code: HSN
• UDI-Device Identifier: 10885862290878
• UDI-Public: 10885862290878
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

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: ANKLE TIBIAL CENTER PUNCH
• Device Catalogue Number: 351-10-26
• Device Lot Number: 287617003
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 04/29/2026
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 10/09/2023; 05/27/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown