BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 3003775 · Received March 14, 2013

    Report

    Report Number
    8030965-2013-10489
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    October 26, 2011
    Report Date
    October 26, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RECEIVED FOR EVALUATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)(6) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS REPORT ONE OF ONE FOR COMPLAINT# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE SURGEON PUT THE NEEDLE THROUGH THE INTERCOSTAL SPACE ON THE FIRST SIDE AND THERE WAS A KINK IN THE ZIPFIX JUST BELOW THE NEEDLE. AS THE SURGEON WAS TRYING TO PASS IT THROUGH THE SECOND SIDE, THE NEEDLE BROKE OFF BEFORE THE SURGEON COULD PULL IT THROUGH. THE SURGEON PULLED THE NEEDLE OUT, DISCARDED IT, AND USED THE EXTRA NEEDLES IN THE PACK TO COMPLETE THE PROCEDURE WITHOUT ANY HARM TO THE PATIENT. THE BROKEN NEEDLES HAVE BEEN DISCARDED BY FACILITY AND ARE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106553 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK JDQ SYNTHES GMBH 2771802

    Patients

    Seq Age Sex Outcome Treatment
    1