BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2130173 · Received May 5, 2011

    Report

    Report Number
    1811755-2011-01620
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    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 HAS BEEN RECEIVED AT THE MANUFACTURE FOR REPAIR AND A CLEAN, LUBE AND ADJUST. ACCORDING TO THE INVESTIGATION DETAILS, THE TECHNICIAN FOUND AN OILY FILM ON THE HANDLE AND AROUND THE BATTERY PLATE OF THE DEVICE. THE SUBSTANCE HAD DISSIPATED AND THE OILY SUBSTANCE COULD NOT BE FOUND TO SAMPLE. THE GEARHEAD BEARING WAS FOUND TO BE CORRODED AND WAS REPLACED IN ADDITION TO OTHER COMPONENTS.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE DEVICE HAD AN OILY SUBSTANCE ON THE OUTER SURFACE OF THE HANDLE. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK