BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 3073096 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-10998
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    June 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION NOTED DURING VISUAL INVESTIGATION SHOWED THAT THE HOLDING PIN OF THE HANDLING LEVER IS MISSING. THIS INVESTIGATION FOUND THAT THE HOLDING PIN OF THE HANDLING LEVER WAS MISSING, WHICH CAUSES THE LEVER TO BE MISPLACED. THE HOLDING PIN WAS NOT SENT ALONG WITH THE DEVICE. THE DEVICE IS STILL FUNCTIONING BUT BECAUSE OF THE MISPLACED LEVER NEEDS MUCH MORE STROKE MOVEMENTS TO BECOME THE SAME RESULT AS WITH AN INTACT INSTRUMENT. THE LEVER HOLDING PIN IS GLUING SAVED AS PER SPECIFICATIONS. WE ARE NOT ABLE TO DETERMINE WHY, WHEN AND WHERE THE PIN GOT LOOSE AND FINALLY FELL OFF. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PRODUCT DEVELOPMENT EVALUATION STATED THAT THE FUNCTION OF THE RETURNED INSTRUMENT WAS TESTED. IT WAS FOUND THAT THE INSTRUMENT DID NOT FUNCTION AS PER THE DESIGN INTEND. THE TRIGGER DOES NOT RETURN TO ITS FORWARD POSITION. THE INVESTIGATION SHOWED THAT THE SCREW, WHICH IS BEARING THE TRIGGER LEVER FOR TENSIONING THE INSERTED IMPLANT, IS MISSING. THE ROOT CAUSE OF THIS INSTRUMENT FAILURE IS RELATED TO THE MISSING SCREW WHICH IS BEARING THE TRIGGER LEVER. THE CAUSE WHY THE SCREW BECAME LOSE AND FELL OUT OF THE INSTRUMENT, CAN NOT MORE BE DETERMINED BY PRODUCT DEVELOPMENT.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CONSULTANT REPORTED: DURING A CABG PROCEDURE, THE ZIPFIX APPLICATION TOOL WOULD NOT TIGHTEN THE ZIPFIX CLOSURES EASILY. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT CHANGING INSTRUMENTS. SURGEON WAS SATISFIED THAT ALL ZIPFIX, CLOSURES WERE THOROUGHLY IMPLANTED IN THIS PROCEDURE. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173299 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX JDQ SYNTHES GMBH 7705157

    Patients

    Seq Age Sex Outcome Treatment
    1