BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SCALED DRILL, AO FITTING

    MDR report key: 18502158 · Received January 12, 2024

    Report

    Report Number
    18502158
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    August 17, 2023
    Report Date
    August 31, 2023
    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

    PATIENT WAS IN OPERATIVE ROOM UNDERGOING OPEN REDUCTION WITH INTERNAL FIXATION (ORIF) LEFT ACETABULUM. IN ORDER TO PLACE PELVIC SCREWS, A LONG STRYKER 2.5MM DRILL BIT WAS BEING USED. DURING DRILL USE, THE TIP OF THE DRILL BIT BROKE OFF AND THIS WAS IMMEDIATELY NOTICEABLE AS FLUOROSCOPY WAS USED THROUGHOUT THE PROCEDURE AS NEEDED. DOCTOR ATTEMPTED TO REMOVE THE THREADS, BUT BECAUSE THEY WERE UNABLE TO BE REMOVED EASILY, THE DRILL TIP WAS LEFT IN THE BONE IN ORDER TO PREVENT FURTHER TRAUMA TO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057980 STRYKER SCALED DRILL, AO FITTING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SA 703966 KU143253

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA Male