BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR SYS6 DT ROTARY

    MDR report key: 1870364 · Received October 11, 2010

    Report

    Report Number
    1811755-2010-01371
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 16, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS EVALUATED AND THE COMPLAINT WAS CONFIRMED. THE HANDPIECE SHOWED EVIDENCE OF DEBRIS AND CORROSION OF COMPONENTS. MAINTENANCE WAS PERFORMED AND THE PRODUCT WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE HANDPIECE BECAME VERY HOT. BACK UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK