BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2201026 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02357
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 9, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE HANDPIECE BEGAN TO SMOKE DURING TESTING. THE DEVICE WAS FOUND TO HAVE A BROKEN CANNULA WHERE THE FRONT HALF OF IT WAS LODGED INTO THE MOTOR PINION. THE SMOKE WAS A RESULT OF THE CANNULA CONTACTING AND RUBBING ON THE GEAR HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING REPAIR THAT THE DEVICE BEGAN TO SMOKE WHEN THE TRIGGER WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 3 HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK