BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER

    MDR report key: 1820034 · Received August 23, 2010

    Report

    Report Number
    1032227-2010-00016
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BRASSELER USA
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REFERENCED IN THE COMPLAINT IS CARBIDE SURGICAL BUR. THE CUSTOMER RETURNED BROKEN PRODUCT ACCUMULATED OVER A PERIOD OF SEVERAL MONTHS. PRIOR TO THIS RETURN, THE CUSTOMER HAS RETURNED PRODUCT FOUR TIMES IN FIVE MONTHS. EACH TIME, THE RETURNED PRODUCT WAS EVALUATED BY COMPANY PERSONNEL. FOR THIS RETURN, THE CUSTOMER RETURNED FIFTEEN (15) BROKEN BURS IDENTIFIED BY LOT NUMBER AND FIVE (5) ADDITIONAL BURS WITH NO LOT NUMBER INDICATED. TWO (2) ADDITIONAL BURS IDENTIFIED WITH A LOT NUMBER WERE ALSO RETURNED. THE CUSTOMER ADVISED THERE HAVE BEEN NO INJURIES ASSOCIATED WITH THE BREAKAGES. TWELVE (12) OF THE BROKEN BURS WERE FROM LOTS KE1VA (1 BUR), KE4L6 (7 BURS), AND 538518 (4 BURS). THE TWO UNBROKEN BURS WERE IDENTIFIED AS LOT J85DC. ALL OF THESE LOTS WERE PACKAGED FROM BULK LOTS 538518 AND 537193. ONE BUR WAS BROKEN IN THE CARBIDE HEAD AND THE REMAINING FOURTEEN WERE BROKEN AT THE NECK WELD. PRODUCT PRODUCED WITH HEAD WELDS HAS BEEN TESTED FOR NECK STRENGTH IN ACCORDANCE WITH ISO 8325:2004 WITH NO FAILURES IN ANY OF THE LOTS TESTED. COMPLAINTS OF BUR BREAKAGE AT THE WELD HAVE BEEN LIMITED TO PRODUCTS WITH THE NECK WELD. CONCLUSION: BREAKAGE IS AN ISOLATED OCCURRENCE IN PRODUCT WITH NECK WELDS.

    Description of Event or Problem · 1

    DENTAL OFFICE ADVISED THE BURS ARE BREAKING AT OR ABOVE SOLDER JOINT WHEN ENGAGED TO TOOTH. THE OFFICE ADVISED THERE WERE NO INJURIES ASSOCIATED WITH THE BREAKAGES AND NO PT INFO OR OTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRASSELER GFF BRASSELER USA H33R.30.016

    Patients

    Seq Age Sex Outcome Treatment
    1