BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3130441 · Received May 24, 2013

    Report

    Report Number
    0001811755-2013-01202
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE HANDPIECE WAS FOUND TO HAVE AN OLD STYLE TRIGGER. AN OLD STYLE TRIGGER DOES NOT HOLD THE MAGNET AS WELL AS A NEW STYLE TRIGGER. THE MAGNET IS USED TO ACTIVATE THE E-BOX WHEN IT COMES IN CLOSE PROXIMITY, SO IF THE MAGNET COMES LOOSE FROM THE TRIGGER AND ATTACHES TO THE E-BOX, IT WILL CAUSE RUN-ON AS SOON AS A BATTERY IS INSERTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORDLESS DRIVER 3 RAN WITHOUT THE TRIGGER BEING DEPRESSED DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES. THE DEVICE WAS THEN SENT TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THE HANDPIECE WOULD OSCILLATE WHEN THE REVERSE TRIGGER WAS PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232562 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1