BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 1407209 · Received June 23, 2009

    Report

    Report Number
    MW5011650
    Event Type
    Malfunction
    Date Received
    June 23, 2009
    Date of Event
    June 11, 2009
    Report Date
    June 15, 2009
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRAOPERATIVELY STRYKER 1.2 MM CROSS CUT FISSURE BUR BROKE IN PATIENT'S MOUTH WHILE IN USE. NO HARM TO PATIENT. BROKEN PIECE FOUND IN SUCTION CANISTER AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS 1.2 MM CROSS CUT FISSURE BUR EJL STRYKER INSTRUMENTS 314010109015017KO

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR