MAUDE Adverse Event Report: EXACTECH, INC. LP TALAR IMPACTOR INSERT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	LP TALAR IMPACTOR INSERT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
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
As reported, during procedure while impacting the talus the black plastic impactor broke.There were no parts, pieces or fragments fell into patient wound site and there was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays received.Product will be return.As of note: "by the look of the x-rays the final talus impaction probably isn¿t achieved but will be once the patient is fully weight bearing".No further information.
Additional Manufacturer Narrative
H3: per the capa investigation, the broken talar impactor cover reported was likely the result of previously unforeseen misuse which led to fracture of the device.The failure of the device indicates stresses applied to the part during use in surgery or during assembly/disassembly were not anticipated properly in the design.

• Brand Name: LP TALAR IMPACTOR INSERT
• 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 ; 3523771140
• MDR Report Key: 17814911
• Report Number: 1038671-2023-02368
• Device Sequence Number: 2342443
• Product Code: HSN
• UDI-Device Identifier: 10885862563415
• UDI-Public: 10885862563415
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 04/18/2024

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: LP TALAR IMPACTOR INSERT
• Device Catalogue Number: 351-07-04
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 04/18/2024
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 110 KG