BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 2945551 · Received February 1, 2013

    Report

    Report Number
    1719045-2013-10007
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED 02/2012. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NOT PRODUCT WAS RECEIVED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORD SHOWED, FOR LOT NUMBER P306380, THE PRODUCT WAS MANUFACTURED BY PIONEER AND CONFIRMED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING AN OPEN REDUCTION INTERVAL FIXATION OF THE LEFT FEMUR, WHILE A CONDULAR PLATE WAS BEING PLACED ON THE FEMUR FOR A PERI-PROSTHETIC FRACTURE BELOW THE HIP, A CABLE TENSIONER MALFUNCTIONED. ONCE THE SURGEON REACHED THE STRENGTH, HE CRIMPED THE CABLE, BUT ONCE HE WAS READY TO LOOSEN THE CABLE, THE CABLE WOULD NOT RELEASE. THE TECH AND SURGEON BOTH ATTEMPTED TO LOOSEN THE CABLE, AND WERE UNABLE TO DO SO. FINALLY, THE SURGEON CUT THE CABLE OFF. ANOTHER SET WAS OPENED, AND ANOTHER CABLE TENSIONER WAS USED TO COMPLETE THE PROCEDURE WITH NO PT HARM. THIS EVENT EXTENDED THE PROCEDURE BY 15 MINUTES. A REPLACEMENT CABLE TENSIONER WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43745 CABLE TENSIONER LXH SYNTHES MONUMENT P306380

    Patients

    Seq Age Sex Outcome Treatment
    1