BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM THREADED GUIDE WIRE

    MDR report key: 2070441 · Received April 19, 2011

    Report

    Report Number
    3003506883-2011-00014
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HWC
    PMA / PMN Number
    K962823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. DEVICE REMAINS IN THE PT. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MFG RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A SCAPHOLUNATE RECONSTRUCTION PROCEDURE, THE 1.25 MM THREADED GUIDE WIRE BROKE AS THE SURGEON WAS PASSING THE 2.0 MM CANNULATED DRILL BIT OVER IT. THE TIP OF THE GUIDE WIRE WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.25MM THREADED GUIDE WIRE 1.25MM THREADED GUIDE WIRE HWC SYNTHES ELMIRA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI DRILL BIT