BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE

    MDR report key: 3071480 · Received April 22, 2013

    Report

    Report Number
    0001811755-2013-00856
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 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

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

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, IT WAS CONFIRMED THAT THE LEAFKEY HOUSING WAS CHIPPING, WHICH CAN OCCUR AS A RESULT OF USE OVER TIME.

    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 NOTED THAT THE BLACK 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 NOTED THAT THE BLACK 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
    171599 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