BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSOURCE

    MDR report key: 16136874 · Received January 11, 2023

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    Report

    Report Number
    16136874
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 5, 2022
    Report Date
    January 3, 2023
    Manufacturer
    GSOURCE LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PATIENT'S ARTHROPLASTY REPLACEMENT TOTAL RIGHT HIP THE TIP OF THE DRILL BIT USED TO DRILL THE HOLES IN THE POSTERIOR FEMUR FOR THE CAPSULAR REPAIR BROKE OFF. THE TIP WAS NOTED TO BE RETAINED IN THE GREATER TROCHANTER, AND CONFIRMED BY X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193373 GSOURCE BIT, DRILL HTW GSOURCE LLC GS 86.8220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown