BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 1942269 · Received December 22, 2010

    Report

    Report Number
    1811755-2010-02114
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVAL WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS THE TRIGGER MAGNET FROM THE LOWER TRIGGER HAS COME OUT OF THE POCKET AND STUCK TO THE EBOX. THE MOTOR 1" MOTOR ASSEMBLY AND THE CD3 ROTARY HANDLE WERE REPLACED IN ADDITION TO OTHER COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN PRIOR TO A SURGICAL PROCEDURE. THERE WAS NO PT INVOLVEMENT. THERE HAS BEEN NO REPORTED PT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 3 INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention