BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE

    MDR report key: 3030072 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01280
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS SENT TO PD FOR EVALUATION: THE IMPLANT IS MANUFACTURED TO THE DEVICE SPECIFICATIONS. THERE IS NO EVIDENCE THAT SUGGEST A MANUFACTURING ISSUE, INJECTION MOLDING, WHICH LED TO THE DEVICE FAILURE. SOME 60,000 IMPLANTS HAVE BEEN SOLD SINCE LAUNCH OF THE SYSTEM FEBRUARY 2011. THE CURRENT OVER ALL DEVICE FAILURE RATE IS 0.16 PERCENT AND IS WITHIN THE EXCEPTED OCCURRENCE LEVEL AS PER THE SYSTEMS DESIGN AND CLINICAL RISK MANAGEMENT FILE. THE PRODUCT THEN WENT TO MANUFACTURING FOR EVALUATION: THE LOCKING PART HAS BEEN CUT IN HALF DURING THE PD EVALUATION. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CAN NOT BE CHECKED FOR DIMENSIONAL ACCURACY. THE DIMENSIONS WERE CHECKED IN THE PD EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING OPEN HEART SURGERY WHILE CLOSING THE STERNUM WITH A MEDIAN STERNOTOMY; ONE ZIPFIX WOULD NOT STAY CLOSED. THE SURGEON REMOVED IT AND IT IS UNCLEAR WHETHER IT WAS REPLACED. IT WAS REPORTED THAT THE STERNUM WAS CLOSED WITH 3 WIRES AND 4 ZIPFIX.

    Description of Event or Problem · 1

    THIS IS 1 0F 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134289 STERNAL ZIPFIX WITH NEEDLE STERILE JDQ SYNTHES GMBH 8080560

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR