BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 1970385 · Received January 18, 2011

    Report

    Report Number
    1811755-2011-00176
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 UNKNOWN, 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 DURING A SURGICAL PROCEDURE, A BUR BROKE OFF IN THE DRILL ATTACHMENT. THERE WAS NO REPORT OF ANY DEVICE FRAGMENTS ENTERING THE SURGICAL SITE. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITHOUT CAUSING A DELAY. NO PATIENT 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 SD/PD MEDIUM CURVED DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO 09168

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK