BEUDAMED
    FDA Adverse Event Other Summary report: N

    HENRY SCHEIN

    MDR report key: 957376 · Received April 13, 2007

    Report

    Report Number
    1416605-2007-00001
    Event Type
    Other
    Date Received
    April 13, 2007
    Date of Event
    March 15, 2007
    Report Date
    April 12, 2007
    Manufacturer
    SHANGHAI DENTAL INSTRUMENT FACTORY
    Product Code
    EKB
    Removal / Correction Number
    Z-0526/0529-5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT TIP WAS BROKEN AT THE TERMINAL SHANK. THE MICROHARDNESS AND MICROSTRUCTURE EVALUATED AT THE TIP WAS NORMAL. THE BROKEN SURFACE REVEALED EXCESSIVE CORROSION CONSISTENT WITH STRESS CORROSION CRACKING. THIS DENTAL EXPLORER REVEALED NO SIMILARITIES TO INSTRUMENTS THAT WERE WITHIN THE RECALLED LOTS (Z-0526/Z0529-5) THAT CONTAINED ABOVE SPECIFICATION HARDNESS VALUES AND IRREGULAR MICROSTRUCTURES. THESE TYPES OF EXPLORERS WITH REGULAR RE-USE HAVE A LIFE EXPECTANCY OF 2 YEARS. THE DATE CODE PRINTED ON THE INSTRUMENT INDICATED THAT THIS INSTRUMENT WAS ALMOST 4 YEARS OLD AT THE TIME OF BREAKAGE. THE PROBABLE CAUSE OF BREAKAGE IS RELATED TO THE CORROSION THAT OCCURRED OVER A PERIOD OF TIME AND THE USE OF THE INSTRUMENT IN THAT IT HAD EXCEEDED ITS USEFUL LIFE. THE DENTAL OFFICE HAD BEEN NOTIFIED ON THREE OCCASIONS ABOUT THE ONGOING RECALL (Z-0526/0529-5), TWICE BY MAIL AND ONCE BY PHONE. THE OFFICE HAD PURCHASED A TOTAL OF 23 INSTRUMENTS SUSPECTED TO BE WITHIN THE SUSPECT DATE RANGE. A TOTAL OF 20 INSTRUMENTS WERE RETURNED BY THIS DENTAL OFFICE DURING THE COURSE OF THE RECALL.

    Description of Event or Problem · 1

    INSTRUMENT TIP BROKE AND PATIENT RECEIVED SMALL CUT ON THE LIP FROM BROKEN TIP. THE TIP WAS RETRIEVED AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN DENTAL INSTRUMENT-EXPLORER EKB SHANGHAI DENTAL INSTRUMENT FACTORY 100-8008 0503

    Patients

    Seq Age Sex Outcome Treatment
    1 Other