BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 DRILL BIT

    MDR report key: 19941175 · Received August 7, 2024

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    Report

    Report Number
    MW5158183
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    June 25, 2024
    Report Date
    August 2, 2024
    Manufacturer
    GSOURCE, LLC.
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRILL BIT BROKE DURING TOTAL HIP ARTHROPLASTY SURGERY. IT IS NOW RETAINED IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636150 2.0 DRILL BIT BIT, DRILL HTW GSOURCE, LLC. G-S 86.8220

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other