BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPS OSCILLATING SAW

    MDR report key: 407743 · Received July 24, 2002

    Report

    Report Number
    1811755-2002-00024
    Event Type
    Injury
    Date Received
    July 24, 2002
    Date of Event
    June 20, 2002
    Report Date
    July 24, 2002
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING HEART REVISION SURGERY, THE SURGEON WAS CUTTING THE STERNUM WHEN THE BLADE SEPARATED FROM THE MOUNT AND STRUCK THE RIGHT VENTRICLE CREATING A SMALL TEAR. THE SURGEON REPAIRED THE TEAR AND FINISHED CUTTING THE STERNUM WITH THE SAME SAW. SURGEON STATED THAT THE PT IS DOING WELL POST-OP WITH NO RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS OSCILLATING SAW SAW, AC, POWERED DZH STRYKER INSTRUMENTS 5100-031-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention