BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL HYBRID

    MDR report key: 23858314 · Received December 19, 2025

    Report

    Report Number
    3007593722-2025-00027
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HWC
    UDI-DI
    M97026000443360
    PMA / PMN Number
    K182677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DYNANAIL MINI EXPLANTED TO CONVERT TO TOTAL ANKLE. THIS COMPLAINT WAS OPENED IN RESPONSE TO A DYNANAIL MINI HEADLESS SCREW AND A DYNANAIL MINI HYBRID SCREW THAT NEEDED TO BE REMOVED IN ORDER TO PUT IN A TOTAL ANKLE REPLACEMENT SYSTEM. THE HAZARD IS AN ANTICIPATED RISK AND IS NOT AN INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. THE IMPLANTS WERE REMOVED TO MAKE ROOM FOR A TOTAL ANKLE REPLACEMENT AND NO ISSUES WITH THE SCREWS WERE IDENTIFIED. THUS, NO FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DYNANAIL MINI EXPLANTED TO CONVERT TO TOTAL ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344453 DYNANAIL HYBRID 4 X 36MM HEADLESS SCREW, DYNANAIL MINI HWC MEDSHAPE, INC. 06101 M97026000443360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other