BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE

    MDR report key: 4902421 · Received July 9, 2015

    Report

    Report Number
    0001811755-2015-02477
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER AFTER PASSING THE FINAL INSPECTION.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SERVICE AT MANUFACTURER FACILITY THAT THE HANDPIECE WAS RUNNING ON ITS OWN WITHOUT ACTIVATION. THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SERVICE AT MANUFACTURER FACILITY THAT THE HANDPIECE WAS RUNNING ON ITS OWN WITHOUT ACTIVATION. THERE WAS 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
    445609 SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1