BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/4" CHUCK W/KEY

    MDR report key: 1894724 · Received November 5, 2010

    Report

    Report Number
    1811755-2010-01607
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED AS OF THE DATE OF THIS REPORT. THIS REPORT WILL BE UPDATED WHEN THE DEVICE IS RETURNED AND AN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE TOP OF THE STERILIZATION CASE WAS REMOVED, THERE WAS A RING OF LUBRICANT ON THE BOTTOM OF THE CASE. THE CASE WAS REMOVED AND REPLACEMENT DEVICES WERE BROUGHT IN TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1/4" CHUCK W/KEY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK