BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 2993942 · Received March 8, 2013

    Report

    Report Number
    8030965-2013-00789
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING A PROCEDURE, THREE OUT OF FIVE ZIP FIX TIES BROKE AFTER BEING APPLIED. AS A RESULT, THE SURGEON REMOVED ALL OF THE ZIP TIES AND USED WIRE CABLES INSTEAD. NO ADVERSE EVENT TO THE PATIENT REPORTED. THIS IS OF 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99203 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK JDQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1