BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX

    MDR report key: 3030146 · Received March 25, 2013

    Report

    Report Number
    3030146
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    January 14, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ZIP TIES WERE IMPLANTED AND UPON TIGHTENING WITH COMPANY GUN, ALL ZIP TIES FAILED TO SECURE STERNUM AND BROKE. STERNAL WIRES WERE THEN UTILIZED FOR SECURING STERNUM. COMPANY WAS NOTIFIED OF DEVICE FAILURE AND WILL PICK UP FAILED PRODUCT FOR REVIEW.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ZIP TIES INTENDED TO CLOSE AND SECURE STERNUM AFTER CORONARY ARTERY BYPASS GRAFT SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122273 STERNAL ZIPFIX CERCLAGE, BONE FIXATION JDQ SYNTHES (USA) * 8019067

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR