BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE

    MDR report key: 3223638 · Received July 12, 2013

    Report

    Report Number
    0001811755-2013-01630
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    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

    THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED AS THE HANDPIECE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE. THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE ALLEGEDLY RAN WITHOUT ACTIVATING THE TRIGGER DURING TESTING OR 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 THE SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE ALLEGEDLY RAN WITHOUT ACTIVATING THE TRIGGER DURING TESTING OR 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
    322671 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