BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC

    MDR report key: 6064261 · Received October 28, 2016

    Report

    Report Number
    1219602-2016-01214
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 4, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION CONDUCTED TO DATE, AWAITING RECEIPT OF DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DRILL COULD NOT CONFIRM THE REPORTED BREAKAGE. THE DRILL SHAFT IS SCORED IN A CIRCULAR MANNER AT SEVERAL PLACES ALONG ITS LENGTH AND SHOWS SIGNS OF MATERIAL LOSS. THE DRILL HEAD IS DULL AND THE FLUTES ARE HEAVILY BURRED. THE DRILL ALSO APPEARS TO HAVE SLIPPED WITHIN THE DRILL CHUCK DURING USE AS THERE IS MAJOR MATERIAL LOSS AT THIS LOCATION. A DEVICE IN THIS CONDITION WOULD REQUIRE THE USE OF EXCESSIVE FORCE IN ORDER TO DRILL. AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE¿. USER ERROR COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE DRILL BROKE. THIS EVENT DID NOT RESULT IN INJURY TO THE PATIENT. NO OTHER CONSEQUENCES RESULTED. THE PROCEDURE WAS NOT DELAYED. IT SEEMS LIKE THE DRILL MAY HAVE BEGAN TO WEAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714639 DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. ED72201108 50435707

    Patients

    Seq Age Sex Outcome Treatment
    1