BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSOURCE SHORT DRILL BIT

    MDR report key: 22897409 · Received August 26, 2025

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    Report

    Report Number
    MW5175240
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 19, 2025
    Report Date
    August 20, 2025
    Manufacturer
    GSOURCE LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A GSOURCE DRILL BIT BROKE OFF WHILE PERFORMING A TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379857 GSOURCE SHORT DRILL BIT BIT, DRILL HTW GSOURCE LLC 86.8221

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female