BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE

    MDR report key: 3070083 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10975
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    October 24, 2011
    Report Date
    October 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. ORIGINAL AWARENESS DATE IS 10/24/2011.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STERNAL CLOSURE AFTER OSTEOTOMY PROCEDURE, WHILE SURGEON WAS TRYING TO WORK THE NEEDLE THROUGH THE SECOND HALF OF STERNUM, THE ZIPFIX BROKE. DUE TO THE SHORTNESS OF THE NEEDLE AND THICKNESS OF THE INTERCOSTAL SPACE, SURGEON WAS REALLY TRYING TO PUSH THE NEEDLE THROUGH AND JUST TWEAK THE ZIPFIX. THE ZIPFIX BROKE OFF WHERE THE LITTLE NOTCH IS BELOW THE NEEDLE. SURGEON WAS ABLE TO IMPLANT THE ZIPFIX WITH NO FURTHER PROBLEMS. THE ZIPFIX WAS IMPLANTED, AND THEREFORE UNAVAILABLE FOR RETURN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171588 STERNAL ZIPFIX WITH NEEDLE STERILE JDQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR