BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM THREADED GUIDE WIRE 150MM

    MDR report key: 1911369 · Received November 23, 2010

    Report

    Report Number
    2520274-2010-00223
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. SUBJECT DEVICE WAS NOT IMPLANTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVAL PROCESS.

    Description of Event or Problem · 1

    WHILE INSERTING A CANNULATED SCREW WITH THE THREADED GUIDE WIRE FOR A TIBIO-TALAR FUSION, THE GUIDE WIRE BROKE INTO SEVERAL PIECES. EACH TIME THE SURGEON TRIED TO ADVANCE THE GUIDE WIRE, IT CONTINUED TO BREAK. SURGEON REAMED OVER WITH A HOLLOW REAMER TO REMOVE ALL THE BROKEN PIECES. AN ADDITIONAL 30-40 MINUTES WERE ADDED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.6MM THREADED GUIDE WIRE 150MM KIRSCHNER/GUIDE WIRES HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR SCREW