BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER CORDLESS DRIVER 3

    MDR report key: 3832978 · Received May 27, 2014

    Report

    Report Number
    0001811755-2014-01935
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED STICKING OF THE TRIGGER WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. DURING TESTING, IT WAS CONFIRMED THAT NO RUN-ON OCCURRED, THEREFORE THERE WAS NO PATIENT OR USER SAFETY RISK ASSOCIATED WITH THIS EVENT. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE AND RETURNED TO THE MANUFACTURER LOANER POOL.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THE TRIGGER OF THE DEVICE WAS GETTING STUCK IN THE ON POSITION, A CONDITION IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO INJURIES OR ADVERSE CONSEQUENCES WERE KNOWN BY THE INITIAL REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THE TRIGGER OF THE DEVICE WAS GETTING STUCK IN THE ON POSITION, A CONDITION IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO INJURIES OR ADVERSE CONSEQUENCES WERE KNOWN BY THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311146 LOANER CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1