BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES

    MDR report key: 1061849 · Received June 13, 2008

    Report

    Report Number
    MW5007322
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 13, 2008
    Product Code
    LRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN OR FOR OPEN REDUCTION AND INTERNAL FIXATION OF TRIMALLEOLAR FRACTURE OF RIGHT ANKLE; WHILE SURGEON WAS USING TWIST DRILL OVER GUIDEWIRE, THE GUIDEWIRE BROKE OFF LEAVING A PIECE IN THE PT'S BONE; THE REST OF THE GUIDEWIRE WAS STUCK IN THE TWIST DRILL; SURGEON HAD TO MAKE 2 SMALL ADDITIONAL INCISIONS TO REMOVE THE BROKEN PIECE. THERE WAS NO HARM TO THE PT; PATIENT DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES GUIDE WIRE 4.0 LRN 292.62

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR