BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM COMPRESSION WIRE

    MDR report key: 2061394 · Received March 18, 2011

    Report

    Report Number
    1719045-2011-00122
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PRODUCT WAS NOT IMPLANTED AND/OR EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A PLATE AND SCREW PROCEDURE THE SURGEON WAS INSERTING A COMPRESSION WIRE INTO THE TWO HOLE STRAIGHT PLATE AND THE WIRE BROKE. SURGEON COULD NOT REMOVE 30 MM OF THE WIRE. SURGEON SHIFTED THE PLATE INSERTED ANOTHER WIRE AND COMPLETED THE INSERTION OF THE PLATE. AS THE SURGEON WAS REMOVING THE SECOND WIRE IT BROKE, LEAVING 30 MM OF WIRE IN THE PATIENT. SURGEON COULD NOT REMOVE THE TWO WIRES, 30 MM EACH WIRE REMAINS IN THE PATIENT. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.6MM COMPRESSION WIRE COMPRESSION WIRE HWC SYNTHES MONUMENT NA 3561120

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PLATE