BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCALED DRILL BIT

    MDR report key: 15720051 · Received November 3, 2022

    Report

    Report Number
    15720051
    Event Type
    Malfunction
    Date Received
    November 3, 2022
    Date of Event
    October 27, 2022
    Report Date
    October 31, 2022
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRILL BIT FRACTURED DURING IMPLANTATION OF SCREWS AND PLATE INTO THE LEFT ACETABULUM. UNABLE TO REMOVE FRACTURED DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522877 SCALED DRILL BIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SA 703966

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA Female