BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 1892531 · Received November 2, 2010

    Report

    Report Number
    1811755-2010-01584
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVAL. DURING INVESTIGATION, FLUID WAS FOUND LEAKING FROM THE BATTERY PLATE. SAMPLES WERE TAKEN OF THE FLUID AND WERE SENT OUT FOR CHEMICAL ANALYSIS, WHICH IS STILL PENDING. SERVICE REPAIRED THE EBOX AND GEARTRAIN. THE BATTERY PLATE AND MOTOR ASSEMBLY WERE REPLACED ALONG WITH OTHER COMPONENTS.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE HANDPIECE HAD FLUID UNDER THE BATTERY PLATE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 3 INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK