BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 3316770 · Received August 29, 2013

    Report

    Report Number
    8030965-2013-04720
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    July 23, 2013
    Report Date
    July 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO PART RECEIVED FOR DHR REVIEW, THEREFORE, DHR REVIEW IS DEEMED TO BE INDETERMINATE. DEVICE HAS BEEN RECEIVED; EVALUATION ANTICIPATED, BUT NOT BEGUN.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, SYNTHES USA DETERMINED THE COMPLAINED EVENT WAS REPORTED IN ERROR. SYNTHES USA IS RETRACTING REPORT #8030965-2013-04720.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION RECEIVED ON 9/17/13 (NOT PREVIOUSLY REPORTED). PRODUCT DEVELOPMENT EVALUATION COMPLETED ON A SECOND GENERATION INSTRUMENT. THE HANDLING TEST WITH 3 IMPLANTS DID NOT SHOW ANY MALFUNCTION OF THE INSTRUMENT. ALL THREE IMPLANTS COULD BE TENSIONED AND CUT WITH THE INSTRUMENT AS PER THE DESIGN INTENT. NO DESIGN RELATED ISSUES OR DEFORMATIONS COULD BE IDENTIFIED ON THE RETURNED INSTRUMENT. THE MANUFACTURER EVALUATION COMPLETED, THE DEVICE WAS RECEIVED FOR EVALUATION WITH NO VISIBLE DAMAGES. NO DEVIATIONS TO THE SPECIFICATION WERE FOUND AND THE DEVICE PASSED THE REQUIRED FUNCTIONAL TEST SUCCESSFULLY. UPON FURTHER REVIEW, OF THE COMPLAINT IT WAS DETERMINED SYNTHES USA ON 10/28/13 THAT THE COMPLAINED EVENT SHOULD REMAIN REPORTABLE.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED DURING A CORONARY ARTERY BYPASS SURGERY AND MIDLINE STERNOTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON WAS CLOSING THE STERNUM AT THE END OF SURGERY AND THE STERNAL ZIPFIX APPLICATION INSTRUMENT FAILED TO OPERATE AND WOULD NOT TIGHTEN WHEN BEING USED. THE SURGEON HAD AN IMMEDIATE ZIPFIX GUN AVAILABLE SINCE THE HOSPITAL HAS FOUR ZIPFIX INSTRUMENTS ON THE CARDIAC CART IN THE SURGERY ROOM. THERE WAS NO TIME DELAY IN SURGERY. THERE WERE NO CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS MADE AVAILABLE. SC PROVIDED CONFIRMATION OF THE DATE OF AWARENESS AS (B)(4) 2013 THROUGH E-MAIL COMMUNICATION ON (B)(4) 2013. THIS IS 1 OF 1 REPORT/S FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427806 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX JDQ SYNTHES GMBH 8310165

    Patients

    Seq Age Sex Outcome Treatment
    1