BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2MM DIAMOND BALL, 5.6CM

    MDR report key: 3050366 · Received April 8, 2013

    Report

    Report Number
    1045834-2013-01366
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    May 3, 2012
    Report Date
    May 4, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FROM THE USER FACILITY. SEVEN REPRESENTATIVE SAMPLES FROM THE SAME LOT WERE TESTED AND MET TEMP SPECIFICATION WITHOUT FRACTURE. NOTE: WARNING AND CAUTIONS FOR ELECTRONIC PNEUMATIC DEVICES: FORCEFUL SIDE LOADING OF DISSECTION TOOL MAY CAUSE FRACTURE OF DISSECTION TOOL, WHICH MAY CAUSE INJURY. REPORT 3 OF 3 IS BEING SUBMITTED TO REPLACE AND REMEDIATE ALL PREVIOUSLY SUBMITTED REPORTS: 1045834-2012-4; 1045834-2012-0004; 1045834-2012-0027, 1045834-2012-0028; 1045834-2012-0027-01, 1045834-2012-0028-01, 1045834-2012-4-03, 1045834-2012-0004-04.

    Description of Event or Problem · 1

    REPORT 1 OF 3: REPORT FROM THE USA. THE SURGEON WAS PERFORMING AN "ENT" PROCEDURE. THE BUR BROKE IN THE PT. TWO ADDITIONAL BURS BROKE DURING THE PROCEDURE. A FOURTH BUR FROM A DIFFERENT UNIDENTIFIED LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. ALL PIECES WERE RETRIEVED. INFO RECEIVED INDICATES THE SURGEON SIDE LOADED THE DEVICE. NO MEDICAL INTERVENTION WAS NECESSARY AND THERE WAS NO IMPACT TO THE PT RELATED TO THE FRACTURED BUR. THOUGH REQUESTED, ADDITIONAL INFO WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144391 2MM DIAMOND BALL, 5.6CM HBE THE ANSPACH EFFORT, INC. F083059945

    Patients

    Seq Age Sex Outcome Treatment
    1