BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-2000

    MDR report key: 2137890 · Received September 18, 2007

    Report

    Report Number
    2025102-2007-00001
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    January 15, 2007
    Report Date
    March 15, 2007
    Product Code
    GFA
    PMA / PMN Number
    K863788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER NOT PROVIDED BY USER FACILITY SO BLADE CANNOT BE TESTED. COMPLAINT CONFIRMED BY MFR ENGINEERING DEPT AND DRAWING REVISION INITIATED.

    Description of Event or Problem · 1

    EVENT DESC: PT UNDERGOING AORTIC VALVE REPLACEMENT DUE TO AORTIC STENOSIS. PT WITH HISTORY OF CABG. SURGEON NEEDED TO REOPEN THE STERNUM AFTER COMPLETING SURGERY BECAUSE THE PT CONTINUED TO BLEED. SURGEON WAS USING HALL SERIES 4 SAW WITH BRASSELER USE KM-279 BLADE. THE SURGEON WAS NOT ABLE TO REOPEN THE STERNUM BECAUSE THE SAW WOULD NOT CUT PROPERLY. SEVERAL SAWS AND BLADES WERE USED WITH THE SAME RESULT. EVENTUALLY WAS ABLE TO REOPEN THE STERNUM. PER THE HALL REP, THE COMBINATION OF THE HALL SAW AND THE BRASSELER BLADE CAUSED THE CAUDAL PIN ON THE SAW TO WEAR DOWN AT A RATE FASTER THAN NORMAL CAUSING THE SAW TO MALFUNCTION. AFTER THIS EVENT, THE HALL SAW WAS USED WITH A HALL BLADE AND FUNCTIONED APPROPRIATELY. WE ARE REPORTING THIS INSTANCE OF MALFUNCTION WITH THE SAW/BLADE COMBINATION SINCE IN THE BRASSELER CATALOG IT STATES THAT THE BRASSELER BLADE IS APPROPRIATE TO USE WITH THE HALL SAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-2000 BLADE, SAW, STERNUM GFA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other