BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 2942955 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-00293
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LOT # WAS REPORTED AS 8019076; THIS IS AN INVALID LOT #. UPON FURTHER INVESTIGATIONS, THE LOT NUMBER WAS DETERMINED TO BE 8019067. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A STERNAL CLOSURE, THE ZIPFIX BAND BROKE WHILE TIGHTENING WITH THE APPLICATION INSTRUMENT. THE ZIPFIX WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48344 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK STERNAL ZIPFIX JDQ SYNTHES GMBH 8019067

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR