BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 1911839 · Received November 23, 2010

    Report

    Report Number
    1811755-2010-01793
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE IF THE RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALL BEARINGS FELL OUT OF THE DEVICE WHILE STILL IN THE INSTRUMENT TRAY. THE DEVICE WAS NOT BEING USED IN THE SURGICAL SITE AT THE TIME OF THE EVENT. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE COLLET INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK