BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA

    MDR report key: 3070462 · Received April 16, 2013

    Report

    Report Number
    MW5029850
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON ATTEMPTED TO USE BONE SHAVER AND REALIZED BLADE WAS IN WRONG WAY. APPEARANCE WAS THAT DEVICE WAS ASSEMBLED WRONG FROM FACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163106 FORMULA DISPOSABLE ARTHROSCOPY BLADE, 5.5MM HRX STRYKER AGRESSIVE PLUS 13021CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR