BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-CUT FISSURE BUR, TAPERED

    MDR report key: 2070562 · Received March 3, 2011

    Report

    Report Number
    9616696-2011-00031
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 4, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO BURS SUBJECT TO THIS INVESTIGATION WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, IT WAS VISUALLY CONFIRMED THE HEAD OF THE BUR WAS BROKEN FROM THE SHANK ON ONE OF THE BURS, THE SECOND BUR REMAINED INTACT. THE RETURNED BURS WERE MEASURED WHERE POSSIBLE AND ALL DIMENSIONAL SPECIFICATIONS WERE MET. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DENTAL PROCEDURE, THE TIP OF TWO BURS BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECES WERE REMOVED FROM THE SURGICAL SITE USING A TWEEZER; RESULTING IN A SURGICAL DELAY OF FIVE MINUTES. IT WAS FURTHER REPORTED THE SURGEON HAS NO CONCERNS ABOUT ANY PIECES BEING LEFT BEHIND IN THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSS-CUT FISSURE BUR, TAPERED DRILLS, BURS, TREPHINES & ACCESSORIES HBE STRYKER IRELAND LTD. 10182017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK