BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSOURCE TWIST DRILL 5"

    MDR report key: 18949068 · Received March 20, 2024

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    Report

    Report Number
    MW5153020
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    March 10, 2024
    Report Date
    March 18, 2024
    Manufacturer
    GSOURCE LLC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HIP HEMIARTHROPLASTY. THREE BONE TUNNELS WERE DRILLED WITH 2.0 DRILL-BIT. IT WAS DURING THIS PART OF THE CASE WHERE THE DRILL-BIT TIP WAS NOTICED TO BE BROKEN AND SEATED INTRA-OSSEOUS IN THE GREATER TROCHANTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317367 GSOURCE TWIST DRILL 5" BIT, DRILL HTW GSOURCE LLC. GS 86.8420 5232309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other