BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 1791639 · Received July 29, 2010

    Report

    Report Number
    1811755-2010-00850
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 7, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND SAMPLES WERE TAKEN OF THE FLUID FOR FURTHER ANALYSIS. GENERAL MAINTENANCE WAS PERFORMED ON THE DEVICE AND A BROKEN GEAR TRAIN WAS FIXED AND CANNULA WAS REPLACED REQUIRES. THIS REPORT WILL BE UPDATED IF THE QUALITY INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING OIL. THIS WAS FOUND DURING STERILE PROCESSING. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCE 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