BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 3021481 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10631
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    April 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE DEVICE WHERE RETURNED IN A CLOSED STATE, AND THE LOCKED DEVICE SEEMED TO WORK AS PER DESIGN INTEND. THE BACK WALL OF THE LOCKING HEAD WAS REMOVED TO PERFORM A VISUAL INSPECTION ON THE LOCKING FEATURE. NO DAMAGES OR DEFORMATIONS WERE VISIBLE TO THE DEVICES LOCKING FEATURE TEETH. ALSO THE TEETH ON THE DEVICE BODY DID NOT SHOW ANY DEFORMATION AS EXPECTED IF TENSION WOULD HAVE BEEN APPLIED TO THE DEVICE. THIS INDICATES THAT THE DEVICE WAS CLOSED BUT DID NOT HOLD THE TENSION APPLIED TO IT. FURTHERMORE, NO OTHER DEFORMATIONS OR DAMAGES WERE VISIBLE ON THE DEVICES OUTER SURFACES. THE INVESTIGATION REGARDING THE IMPLANT FAILURE IS INCONCLUSIVE; A HANDLING ERROR BY THE USER CANNOT BE EXCLUDED. THE MANUFACTURING EVALUATION SHOWED THE BACKSIDE OF THE LOCKING FEATURE IS CUT AWAY. THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE BECAUSE THE BACKSIDE OF THE LOCKING FEATURE WAS CUT AWAY FOR INVESTIGATION. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A TWO VESSEL CABG, THE SURGEON WAS USING THE ZIPFIX WITH NEEDLE TO SECURE THE STERNUM, WHEN THE SURGEON INSERTED THE ZIPFIX, TIGHTENED IT, AND CUT IT, THE ZIPFIX OPENED BACK UP. THE SURGEON REMOVED IT AND REPLACED IT WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. AFTERWARD, THE SURGEON INDICATED THE ISSUE WAS A TECHNIQUE ISSUE. THE ZIPFIX HAD BEEN OVER-TENSIONED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123379 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK JDQ SYNTHES GMBH 2808513

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR