BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 1912871 · Received November 23, 2010

    Report

    Report Number
    1811755-2010-01794
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 1, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL OPERATED WHEN THE TRIGGER WAS NOT ACTIVATED. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITH NO REPORT OF A DELAY. NO PT OR USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE SUMEX DRILL DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK