BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM COMPRESSION WIRE 25MM THREAD/150MM LENGTH

    MDR report key: 2516055 · Received March 29, 2012

    Report

    Report Number
    1719045-2012-00200
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 2, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING AN MTJ FUSION, THE COMPRESSION WIRE BROKE ON REMOVAL. SURGEON ATTEMPTED TO REMOVE THE WIRE HOWEVER A FRAGMENT OF THE GUIDE WIRE WAS NOT RETRIEVED, AND REMAINS IN THE PT'S BONE. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THE HOSPITAL DISCARDED THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.6MM COMPRESSION WIRE 25MM THREAD/150MM LENGTH COMPRESSION WIRE HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1