BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JONES UNION

    MDR report key: 23587790 · Received November 18, 2025

    Report

    Report Number
    3007289093-2025-00014
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 18, 2025
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWX
    UDI-DI
    00842078115596
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE DOCTOR WAS USING THE TAP FROM THE JONES UNION SYSTEM IT BENT, CAUSING THE TAP TO WORK INEFFICIENTLY. THIS RESULTED IN THE SCREW NOT BEING ABLE TO COMPRESS THE BONE. THE REP HYPOTHESIZED IT POTENTIALLY COULD HAVE RESULTED IN BENDING DUE THE WIRE POTENTIALLY BENDING AFTER PLACEMENT. THE ISSUE WAS ADDRESSED BY SIZING UP ON THE SCREW, PATIENT WAS ABLE TO GET A LITTLE COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363111 JONES UNION TAP HWX EXTREMITY MEDICAL, LLC. 00842078115596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown