BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES SCREWDRIVER

    MDR report key: 6242994 · Received January 9, 2017

    Report

    Report Number
    MW5067176
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 9, 2017
    Manufacturer
    SYNTHES INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT RING FINGER AND A CLOSED REDUCTION OF THE LEFT SMALL FINGER WHEN THE SCREWDRIVER USED TO INSERT THE SCREWS BROKE INTO TWO PIECES. THE PIECES WERE REMOVED FROM THE STERILE FIELD AND AN X-RAY TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18214 SYNTHES SCREWDRIVER SYNTHES SCREWDRIVER HXX SYNTHES INC. 03.130.010 T4
    18215 SYNTHES SCREWDRIVER SYNTHES SCREWDRIVER HXX SYNTHES INC. 9923513

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR