BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.6 K WIRE

    MDR report key: 562873 · Received December 30, 2004

    Report

    Report Number
    562873
    Event Type
    Other
    Date Received
    December 30, 2004
    Date of Event
    August 21, 2004
    Report Date
    December 20, 2004
    Manufacturer
    SYNTHES USA, INC.
    Product Code
    DQX
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT ORIF, OPEN REDUCTION WITH INTERNAL FIXATION, AFTER FALL. GUIDEWIRE BROKE IN BONE AND LEFT THERE BY SURGEON. ORIF PERFORMED WITH 2 PARTIALLY THREADED CANNULATED CANCELLOUS 4.5 SYNTHES SCREWS AND ONE K WIRE. A COUPLE OF K WIRES WERE PUT IN AS GUIDE WIRES FOR THE CANNULATED SCREW SYSTEM. SURGEON STARTED TO DRILL THE FIRST ONE AND IT BROKE THE K WIRE WHICH PREVENTED PUTTING IN A SECOND K WIRE WHICH PREVENTED PUTTING IN A SCREW BECAUSE IT HAD NOT GONE THROUGH ALL THE WAY AND THE K WIRE WAS LEFT IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.6 K WIRE GUIDEWIRE DQX SYNTHES USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR NO OTHER THERAPIES