BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 2033696 · Received March 23, 2011

    Report

    Report Number
    1811755-2011-00908
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER, AND THE COMPLAINT WAS CONFIRMED. BASED ON THE DEVICE EVALUATION, A BROKEN BUR WAS FOUND WITHIN THE DRILL ATTACHMENT. THE CAUSE OF THE BUR BREAKAGE IS UNK; HOWEVER, THE INVESTIGATION IS ON-GOING. THE DEVICE COULD NOT BE REPAIRED AND THEREFORE WAS NOT RETURNED TO THE USER FACILITY. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BUR BROKE AND REMAINED STUCK IN THE DRILL ATTACHMENT. THERE WAS NO PT INVOLVEMENT, NO REPORT OF USER INJURY, AND NO ADVERSE CONSEQUENCES WERE ALLEGED FROM THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD/PD MEDIUM CURVED DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO 10287

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK