BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 2000 STERNUM SAW

    MDR report key: 103141 · Received July 3, 1997

    Report

    Report Number
    1811755-1997-00059
    Event Type
    Injury
    Date Received
    July 3, 1997
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHIEF OF CARDIAC SURGERY WAS EVALUATING REPS/REGIONS SAMPLE EQUIPMENT. SAW POWERED UP, WORKED FINE, THEN STALLED. DR ALLEGES SAW SHREDDED STERNUM WHICH REQUIRED BASKET WEAVING THE STERNUM BACK TOGETHER USING WIRES. REP PULLED 4 SAMPLE SAWS AND 2 SAMPLE CHARGERS, BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 2000 STERNUM SAW SAW DWH STRYKER INSTRUMENTS 2107-000-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention