BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR SYS6 ST ROTARY

    MDR report key: 1960756 · Received December 16, 2010

    Report

    Report Number
    1811755-2010-02042
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE QUALITY INVESTIGATION IS ONGOING AND THIS RECORD WILL BE UPDATED WHEN IT IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE DEVICE WAS AT THE MANUFACTURER FOR A REPAIR, IT WAS FOUND THAT THE DEVICE CONTINUES TO RUN AFTER THE TRIGGER WAS LET GO. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    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