BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 4110332 · Received September 23, 2014

    Report

    Report Number
    0001811755-2014-03335
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    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 EVENT FOR LEAKING WAS CONFIRMED BY THE REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY AND VISUAL INSPECTION. AN OILY SUBSTANCE WAS FOUND ON THE OUTSIDE OF THE DEVICE. THE E BOX WAS DETERMINED IN NEED OF REPLACEMENT AS THE SEAL WAS BROKEN. THE AFFECTED HANDLE AND BUSHING WERE REPLACED ALONG WITH OTHER COMPONENTS NOT ASSOCIATED WITH THE FAILURE. THE DRIVER PASSED ALL FINAL INSPECTION ACTIVITIES AND RETURNED TO THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SERVICE AT MANUFACTURER FACILITY THAT THE CORDLESS DRIVER HAS AN OILY FILM ON THE OUTSIDE OF THE HANDLE. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591897 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1