BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS STONECUTTER

    MDR report key: 1991572 · Received February 9, 2011

    Report

    Report Number
    1991572
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 9, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROOM SET UP, IT WAS NOTICED THAT THE BLADE WAS STICKING. THE DEVICE WAS REMOVED IMMEDIATELY AND NEVER MADE IT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS STONECUTTER ARTHROSCOPE, BURR HRX SMITH & NEPHEW, INC. 7205330 50546377

    Patients

    Seq Age Sex Outcome Treatment
    1 *