BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALL LARGE BONE OSCILLATING BLADE

    MDR report key: 956750 · Received November 30, 2007

    Report

    Report Number
    1017294-2007-00843
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Report Date
    November 2, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM RECEIVED FROM THE USER FACILITY. INVESTIGATION RESULTS: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION FOUND NO DAMAGE TO THE OUTER BOX CONTAINING THIS PRODUCT BUT FOUND A CRACK/HOLE IN THE CORNER OF THE BLISTER PACKAGE WHICH CONTAINS THE BLADE. FURTHER INVESTIGATION FOUND THAT THE STERILITY OF THE PRODUCT IS COMPROMISED. A REVIEW OF PRODUCT HISTORY FOR THE PAST 2 YEARS FOUND NO OTHER SIMILAR REPORTS FOR THIS PROBLEM. THERE IS ONE OTHER REPORTED PROBLEM FOR THIS LOT NUMBER AND BLADE PACKAGED IN THE SAME BOX. THIS BLADE IS SOLD STERILE, IN A BOX OF 5.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR DISTRIBUTOR IN JAPAN THAT THE 9800 PACKAGE CONTAINING THIS STERILE BLADE HAS A CRACK IN THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL LARGE BONE OSCILLATING BLADE OSCILLATING BLADE DZH CONMED LINVATEC NA BBD24642

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR