BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK 5U

    MDR report key: 3192511 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03967
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    April 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE DEVICE FAILURE IS RELATED TO THE LARGER OPENING WITHIN THE LOCKING HOUSING. A POTENTIAL REASON FOR THE LOCKING FEATURE DEFORMATION WITHIN THE LOCKING HOUSING COULD BE EXPLAINED TO THE INCORRECT ORIENTATION OF THE APPLICATION INSTRUMENT. THE CAUSE OF THE DEVICE FAILURE IS NOT DESIGN OR SPECIFICATION RELATED. THE INCORRECT ORIENTATION OF THE APPLICATION INSTRUMENT WHILE TENSIONING AS ROOT CAUSE OF THE DEVICE FAILURE CANNOT BE CONFIRMED NOR EXCLUDED. THEREFORE, THE ROOT CAUSE IS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT LOOSENED. SURGEON HAD TIGHTENED THE IMPLANT WITH HIS FINGER AND THEN USED THE TENSION DEVICE. THIS WAS PERFORMED PER TECHNIQUE GUIDE. WHEN CHECKING FOR FINAL STABILITY, THE IMPLANT LOOSENED. THE SURGEON TRIED TO RETIGHTEN THE IMPLANT AGAIN WITH HIS HANDS BUT IT WOULD NOT HOLD TENSION AS THE IMPLANT FREELY MOVED THROUGH THE LOCKING DEVICE. HE CUT IMPLANT AND REMOVED IT FROM THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294283 STERNAL ZIPFIX W/NEEDLE PEEK 5U JDQ SYNTHES GMBH 7795441

    Patients

    Seq Age Sex Outcome Treatment
    1