BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE SUMEX DRILL

    MDR report key: 1813005 · Received August 11, 2010

    Report

    Report Number
    1811755-2010-00926
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE EQUIPMENT TESTING CONDUCTED BY THE MANUFACTURER'S SALES REPRESENTATIVE, THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR IN THE SURGICAL ENVIRONMENT SO THERE WAS NO PT INVOLVEMENT. NO 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 REPAIR CORE SUMEX DRILL DRILLS, SURGICAL, ENT (ELECTRIC, OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK