BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE TRIGGER ROTARY

    MDR report key: 1945841 · Received December 28, 2010

    Report

    Report Number
    1811755-2010-02128
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURNED TO THE MFR AND A SAMPLE WAS TAKEN OF THE SUBSTANCE LEAKING FROM THE DEVICE FOR FURTHER EVAL. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE HANDPIECE WAS LEAKING OIL. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK