BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE

    MDR report key: 3092439 · Received May 3, 2013

    Report

    Report Number
    0001811755-2013-01024
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 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

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF LEAFKEY HOUSING CHIPPING WAS CONFIRMED. THE HOUSING COATING CAN CHIP OVER TIME DUE TO USE AND WAS THE MOST LIKELY CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE. FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FAILURE ANALYSIS IT WAS REPORTED THAT THE LEAFKEY HOUSING WAS CHIPPING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FAILURE ANALYSIS IT WAS REPORTED THAT THE LEAFKEY HOUSING WAS CHIPPING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193632 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