BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SAGGITAL SAW

    MDR report key: 2093901 · Received May 11, 2011

    Report

    Report Number
    MW5020605
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DURING RE-OP PROCEDURE DUE TO GRAFT FAILURE S/P DHT, IT WAS NOTED THAT A PIECE OF THE SAW BLADE ATTACHED TO THE HANDLE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SAGGITAL SAW MICRO SAGGITAL SAW GFA STRYKER INSTRUMENTS 3151001102790175X

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR