BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK 5U

    MDR report key: 3193368 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03351
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    September 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE LOCKING FEATURE HAS SOME DEFORMATIONS AND A SLIGHT TWIST TO THE RIGHT HAND SIDE. WHEN THE USER IS CUTTING THE NEEDLE FROM THE IMPLANT, AS PER THE CURRENT TECHNIQUE GUIDE, INDICATED AT THE DEDICATED LOCATION JUST BEHIND THE NEEDLE AND FORCING THE CUT END INTO THE LOCKING HOUSING IN AN ANGLE WITH GREAT FORCE, IT IS POSSIBLE TO DAMAGE THE LOCKING FEATURE TO SUCH EXTENT THAT THE LOCKING FUNCTION IS COMPROMISED SO THAT IT IS NOT POSSIBLE TO APPLY ANY TENSION TO THE IMPLANT. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY AFTER FINAL TIGHTENING. THE DEVICE BROKE DURING THE SURGERY. THERE WAS NO SIGNIFICANT INCREASE IN THE SURGERY TIME. THE BROKEN FRAGMENT WAS IN THE PATIENTS STERNUM, IT WAS RETRIEVED FROM THE PATIENTS BODY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292886 STERNAL ZIPFIX W/NEEDLE PEEK 5U JDQ SYNTHES GMBH 2677723

    Patients

    Seq Age Sex Outcome Treatment
    1