BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 3063655 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10850
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    June 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. PRODUCT DEVELOPMENT DID NOT FIND ANY REASONS, DEFORMATIONS OR DAMAGES TO THE RETURNED DEVICES WHICH WOULD INDICATE THE ROOT CAUSE OF THE DEVICES FAILURE. ONE OF THE DEVICES EXHIBITED SIGNS OF THE NEEDLED BEING REMOVED AT THE BENDING NOTCH OF THE DEVICE. THE FRACTURED SURFACE INDICATED THAT THE NEEDLE WAS NOT REMOVED WITH A CUTTER INSTRUMENT AS SHOWN IN THE SYSTEMS TECHNIQUE GUIDE, BUT INSTEAD SNAPPED OFF THE IMPLANT DEVICE. ALL DEVICES PASSED SUCCESSFULLY THE REQUIRED FUNCTIONAL TESTS PERFORMED DURING THE PD EVALUATION. THE INVESTIGATION REGARDING THIS COMPLAINT IS INCONCLUSIVE. MANUFACTURING EVALUATION STATED THAT 5 ZIPFIX DEVICES WITHOUT THEIRS NEEDLES ATTACHED WERE RECEIVED. THE RELEVANT DIMENSIONS WERE NOT ABLE TO BE CHECKED TO THE PRINT SPECIFICATIONS DUE TO THE WEAR CAUSED DURING USE AND THE PRODUCT DEVELOPMENT EVALUATION TESTS CONDUCTED. NO FUNCTIONAL ISSUES WERE DETECTED; THE FAILURE AS PER EVENT DESCRIPTION COULD NOT BE DUPLICATED. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    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. PRODUCT EXPIRATION DATE IS 11/30/2016. PRODUCT MANUFACTURED ON 01/25/2012. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, SURGEON WAS IMPLANTING THE ZIPFIXES AND ALL FIVE (5) OF THE STERNAL ZIP FIX TIE WOULD NOT RATCHET DOWN AND HOLD. THE LOCKING MECHANISM ON THE ZIPFIX SEEMED TO BE BROKEN. THE ZIPFIX IMPLANTS WERE REMOVED BEFORE CLOSURE AND WERE NOT USED DURING THE PROCEDURE. SURGEON USED WIRES TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164233 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK JDQ SYNTHES GMBH 2824021

    Patients

    Seq Age Sex Outcome Treatment
    1