BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2042808 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01015
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. THE COMPLAINT WAS NOT DUPLICATED. ACCORDING TO THE INVESTIGATION DETAILS, THE MOTOR CONTROLLER ASSEMBLY WAS CORRODED AND NEEDED TO BE REPLACED IN ADDITION TO SEVERAL OTHER COMPONENTS. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT/USER INJURY OR PROCEDURAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 2 HANDPIECE GET STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK