BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK 5U

    MDR report key: 3171599 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02813
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    October 27, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION HAS SHOWN THAT TWO OF THE COMPLAINED ZIPFIX IMPLANTS DO NOT SHOW ANY DAMAGE TO THEIR LOCKING MECHANISM, AND APPEAR TO HAVE BEEN REMOVED INTRA-OPERATIVELY BY CUTTING THE IMPLANT BODY. THE REMAINING TWO ZIPFIX IMPLANTS SHOWED SOME DEFORMATIONS ON THE INNER LOCKING FEATURES. DUE TO PREVIOUSLY RECEIVED MARKET FEEDBACK THE FAILURE OF THIS PHENOMENON HAS BEEN IDENTIFIED; IF THE CUT END IS FORCED INTO THE LOCKING HOUSING IN AN OFF ANGLE THEN IT IS POSSIBLE TO DAMAGE THE LOCKING FEATURE TO SUCH AN EXTENT THAT THE LOCKING FUNCTION IS COMPROMISED. THEN THE CORRECT TENSIONING OF THE IMPLANT IS NOT POSSIBLE. A CAPA HAS BEEN INITIATED AND THE IMPROVED DESIGN IS ALREADY AVAILABLE. THE IMPLANTS WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE ZIPFIX DID NOT WORK AS INTENDED. IMPLANT FAILURE HAPPENED INTRA-OPERATIVELY WITH NO SIGNIFICANT INCREASE OF OR TIME. STERNUM WAS CLOSED WITH NEW PACK OF 5 ZIPFIX. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272610 STERNAL ZIPFIX W/NEEDLE PEEK 5U JDQ SYNTHES GMBH 2695209

    Patients

    Seq Age Sex Outcome Treatment
    1