BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL 5" STR SHANK DOUBLE

    MDR report key: 20915687 · Received December 11, 2024

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    Report

    Report Number
    MW5163564
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    December 9, 2024
    Report Date
    December 9, 2024
    Manufacturer
    GSOURCE, LLC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP OF DRILL BIT BROKE DURING SURGERY AND LEFT IN PT SINCE REMOVING WOULD CAUSE MORE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377019 TWIST DRILL 5" STR SHANK DOUBLE BIT, DRILL HTW GSOURCE, LLC. GS 86.8427 5232442

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other