BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE WITH OLIVE, DIAMOND POINT HOFFMANN LRF Ø1.8 X 450MM

    MDR report key: 3200811 · Received July 2, 2013

    Report

    Report Number
    0008031020-2013-00212
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K113327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS USING A HOFFMAN EXTERNAL FIXATION WHILE DOING A PROCEDURE ON PATIENTS' LEFT SIDE AND DURING THE TENSIONING PROCESS, ONE OF THE WIRES WAS AT AN OBLIQUE ANGLE AND THE WIRE BROKE WHILE BEING TENSIONED. THE SURGEON REPLACED THE BROKEN WIRE AND COMPLETED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301568 WIRE WITH OLIVE, DIAMOND POINT HOFFMANN LRF Ø1.8 X 450MM IMPLANT KTT STRYKER OSTEOSYNTHESIS-SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention