BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 3083742 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00957
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    WHILE TESTING THE CORDLESS DRIVER 2 HANDPIECE DURING ROUTINE SERVICING THE DEVICE WAS SLOW TO STOP. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183384 CORDLESS DRIVER 2 HANDPIECE ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1