BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 15672620 · Received October 26, 2022

    Report

    Report Number
    15672620
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    September 17, 2022
    Report Date
    October 3, 2022
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PROCEDURE WHEN DRILLING FOR SCREW PLACEMENT, THE STRYKER 4.2 X 185MM FREEHAND DRILL, THE TIP OF THE DRILL BIT, 10 MM, BROKE INSIDE THE PATIENT'S FEMUR. IT IS HARD TO DETERMINE WHAT MAY HAVE CAUSED THIS, HARD BONE, PUSHING TOO HARD ON THE DRILL BIT, ETC. DOCTOR UNABLE TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801759 NA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SA 2351-4218S KU151748

    Patients

    Seq Age Sex Outcome Treatment
    1 6205 DA Male