BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR SYS5 ROT DUAL TRIGGER

    MDR report key: 1873424 · Received September 17, 2010

    Report

    Report Number
    1811755-2010-01194
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN EVALUATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PROCEDURE, A SUBSTANCE DESCRIBED AS BLOOD WAS FOUND INSIDE OF THE HANDPIECE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR SYS5 ROT DUAL TRIGGER INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK