BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    MDR report key: 2496780 · Received March 15, 2012

    Report

    Report Number
    1811755-2012-00956
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 25, 2012
    Report Date
    February 25, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR SERVICE AND EVAL, AND THE REPORTED CONDITION OF THE DEVICE RUNNING ON ITS OWN WAS DUPLICATED. CORROSION WAS IDENTIFIED IN THE DEVICE. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE REAR MOTOR ASSEMBLY AND LARGE BEARINGS, WHICH WERE EACH REPLACED ALONG WITH OTHER COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FIELD SERVICE TECH THAT THERE WAS A RUN-ON CONDITION WITH THE HANDPIECE WHILE THE EQUIPMENT WAS BEING TESTED. THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK