BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK 5U

    MDR report key: 3171629 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02962
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    January 26, 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). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THERE IS EVIDENCE THAT THE USER APPLIED SOME ROTATIONAL (IN AXIS) AND SIDE BENDING MOTION TO THE DEVICE DURING ITS TRANSSTERNAL APPLICATION. THIS MOTION IN COMBINATION WITH A PULL FORCE APPLIED, RESULTED IN TOO MUCH DUCTILE DEFORMATION TO THE CROSS SECTIONAL AREA OF THE BENDING NOTCH, CAUSING THE NEEDLE TO PREMATURELY SNAP OFF THE IMPLANT. SYNTHES DOES NOT BELIEVE THAT THIS A DESIGN ISSUE.

    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. PLACEHOLDER.

    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 ZIP FIX DEVICE RIPPED AT APPLICATION WHEN PULLED THROUGH. THE DEVICE WAS BEING IMPLANTED AT THE MANUBRIUM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272620 STERNAL ZIPFIX W/NEEDLE PEEK 5U JDQ SYNTHES GMBH 2737790

    Patients

    Seq Age Sex Outcome Treatment
    1