BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT LONG SABER ATTACHMENT

    MDR report key: 1894788 · Received November 5, 2010

    Report

    Report Number
    1811755-2010-01613
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MFR AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED, AND EXTENSIVE CORROSION AND DEBRIS WAS DISCOVERED WITHIN VARIOUS COMPONENTS, INCLUDING THE BEARINGS. THE PRESENCE OF CORROSION AND DEBRIS CAN LEAD TO INCREASED FRICTION BETWEEN ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED. IMPROPER OR INADEQUATE CLEANING/STERILIZATION TECHNIQUES CAN CONTRIBUTE TO THE BUILDUP OF CORROSION AND DEBRIS WITHIN THIS DEVICE. THE DRILL ATTACHMENT COULD NOT BE REPAIRED AND WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EQUIPMENT EVAL CONDUCTED BY A MFR FIELD SERVICE TECHNICIAN, THE DEVICE HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT LONG SABER ATTACHMENT DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC. ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK