BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 2448078 · Received February 7, 2012

    Report

    Report Number
    3003787298-2012-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 2, 2012
    Report Date
    January 13, 2012
    Manufacturer
    SYNTHES INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NONCONFORMANCES RELATED TO THIS COMPLAINT WERE FOUND IN DHR. ALL FEATURES RELATED TO THIS COMPLAINT THAT COULD BE MEASURED DURING THIS EVALUATION MEET SPECIFICATIONS. ADDITIONAL INFO FROM THE VOLUNTARY REPORT: (B)(4) 2012.

    Description of Event or Problem · 1

    MED WATCH (B)(4) RECEIVED, COPY WILL BE SENT WITH INITIAL. DURING A CLOSED REDUCTION AND PERCUTANEOUS SCREW FIXATION OF THE RIGHT SACROILIAC JOINT POST FRACTURE AN A-O SCREWDRIVER TIP BROKE OFF IN PT'S PELVIS WHEN PHYSICIAN ADVANCED THE SCREW BY HAND. UNABLE TO RETRIEVE THE SCREWDRIVER TIP AS IT IS IMBEDDED IN THE PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HXX SYNTHES INC. A4ED778

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other