BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    MDR report key: 2994279 · Received March 8, 2013

    Report

    Report Number
    0001811755-2013-00467
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. THE HANDPIECE HAD RUN-ON DUE TO A DAMAGED TRIGGER ASSEMBLY. BASED ON A REVIEW OF COMPLAINT TRENDING, DAMAGE TO THE TRIGGER CAN CAUSE IT TO STICK, RESULTING IN RUN-ON.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING EVALUATED BY A MANUFACTURER FOREIGN SUBSIDIARY A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. (B)(4): THE DEVICE IS BEING EVALUATED BY A MANUFACTURER FOREIGN SUBSIDIARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CONTINUOUS ROTATION OF THE MOTOR OF THE SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE UPON CONNECTION WITH THE BATTERY. THE EVENT OCCURRED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CONTINUOUS ROTATION OF THE MOTOR OF THE SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE UPON CONNECTION WITH THE BATTERY. THE EVENT OCCURRED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99405 SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1