MAUDE Adverse Event Report: EXACTECH, INC. ANKLE SZ 4 LOCKING CLIP; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-10-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 72 yo male patient, who had their left ankle implanted, underwent a revision procedure.The tibial clip was found on a lateral x-ray to be coming out of the poly.The poly was exchanged with a new tibial clip.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are available for return.No device images were available.No further information.This is 1 of 2 reports.
Additional Manufacturer Narrative
D10: (b)(6) 350-01-04 - talar implant sz 4 lt.(b)(6) 350-11-04 - tibial plate fb sz 4 lt.(b)(6) 351-50-00 - model tibia talus report.(b)(6) 351-90-21 - 3.5" pin pouch.(b)(6) 351-90-21 - 3.5" pin pouch.(b)(6) 351-90-22 - 2.5" pin.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d.The disassembly reported was likely the result of improper assembly during the index surgery.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ANKLE SZ 4 LOCKING CLIP
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22800987
• Report Number: 1038671-2025-02753
• Device Sequence Number: 8950704
• Product Code: HSN
• UDI-Device Identifier: 10885862302021
• UDI-Public: 10885862302021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 350-10-04
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male