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

Model Number LP TALAR IMPACTOR INSERT

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 324230449
• Report Number: 1038671-2023-02368
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862563415
• UDI-Public: 10885862563415
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 110 KG