BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 1894789 · Received November 5, 2010

    Report

    Report Number
    1811755-2010-01619
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 11, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT THE DEVICE HAS NOT BEEN RECEIVED. THIS REPORT WILL BE UPDATED WHEN THE DEVICE IS RETURNED AN EVAL CAN BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING OIL WHEN IT WAS BEING WASHED AFTER A PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK