BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK 5U

    MDR report key: 3192544 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04126
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE DEVICE FAILURE WAS RELATED TO THE LOCKING FEATURE DEFORMATIONS. THE DEFORMATIONS TO THE FIRST TOOTH OF THE LOCKING FEATURE WERE PRODUCED BY THE INCREASED CROSS SECTIONAL AREA, WHERE THE NEEDLE WAS TWISTED OFF THE DEVICE. THIS INCREASED CROSS SECTIONAL AREA FIRSTLY WAS PUSHING THE LOCKING FEATURE BEYOND ITS ELASTIC STATE AGAINST THE BACK WALL AND SECONDLY DEFORMED THE FIRST TOOTH OF THE LOCKING FEATURE. THESE DEFORMATIONS WERE THE REASON FOR THE DEVICE TO FAIL. THE INVESTIGATION REGARDING THE RETURNED DEVICE CONCLUDES THAT THE ROOT CAUSE IS A HANDLING ERROR. THE TECHNIQUE GUIDE STATES IN STEP 2 THAT THE NEEDLE SHOULD BE REMOVED BY MEANS OF CUTTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIPFIXE NOT WORKING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292253 STERNAL ZIPFIX W/NEEDLE PEEK 5U JDQ SYNTHES GMBH 7816978

    Patients

    Seq Age Sex Outcome Treatment
    1