BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR SYS6 ST ROTARY

    MDR report key: 1791522 · Received July 21, 2010

    Report

    Report Number
    1811755-2010-00816
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND SAMPLES OF THE FLUID WERE TAKEN FOR FURTHER ANALYSIS. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. THIS REPORT WILL BE UPDATED WHEN THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING AN UNDESCRIBED FLUID. IT IS UNK, IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES AT THIS TIME. ATTEMPTS ARE BEING MADE TO COLLECT ADDITIONAL INFO FROM THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR SYS6 ST ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK