BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3192314 · Received June 26, 2013

    Report

    Report Number
    3192314
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES (USA) PRODUCTS, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING THE REVISION OF THE RIGHT FEMUR FIXATION A SCREW REMOVAL INSTRUMENT BROKE IN THE WOUND. THE PORTION OF THE INSTRUMENT THAT BROKE INSIDE OF THE INCISION WAS LODGED IN A SCREW IN THE BONE AND WAS UNABLE TO BE REMOVED. THE REST OF THE INSTRUMENT WAS REMOVED; THE MD DECIDED TO LEAVE THE PORTION OF THE INSTRUMENT IN THE WOUND AND FORGO AN X-RAY BECAUSE IT WOULD NOT BE ABLE TO BE SEEN LODGED WITHIN THE SCREW IN THE BONE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291068 * SCREW HWC SYNTHES (USA) PRODUCTS, LLC 309.510 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR