BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM COMPRESSION WIRE 20MM THREAD/150MM LENGTH

    MDR report key: 2425151 · Received January 17, 2012

    Report

    Report Number
    1719045-2012-00033
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. PATIENT WEIGHT AND HISTORY WERE PROVIDED.

    Description of Event or Problem · 1

    DURING A FIRST MPJ FUSION PROCEDURE, THE END OF THE K-WIRE SNAPPED OFF, AND WAS LEFT IN THE PATIENT. SURGEON USED A SECOND K-WIRE, AND IT ALSO SNAPPED AND A PORTION OF THE WIRE WAS LEFT IN THE BONE. A THIRD WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS IS THE SECOND OF TWO REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.6MM COMPRESSION WIRE 20MM THREAD/150MM LENGTH COMPRESSION WIRE HWN SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR WIRE