BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT, 2.0MM (AO)

    MDR report key: 8735136 · Received June 26, 2019

    Report

    Report Number
    1220246-2019-01173
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 26, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867052840
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE AR-8944-22 DRILL BIT (APPROXIMATELY 15-20MM) BROKE OFF WHILE IN BONE DURING A LAPIDUS PROCEDURE. THE REP STATED THE BROKEN PIECE WAS NOT NOTICED UNTIL FINAL X-RAYS WERE BEING TAKEN. THE REP STATED THEY HAD ALREADY LEFT THE OR, BUT RETURNED TO THE ROOM ONCE NOTIFIED. THE BROKEN FRAGMENT REMAINS IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 06/17/2019: THE REP STATED IT IS UNKNOWN IF THE SURGEON PLANS TO PERFORM A REVISION SURGERY TO REMOVE THE FRAGMENT. THE PROCEDURE WAS OPEN, AND THERE ARE NOT ANY PORTIONS OF THE DRILL BIT AVAILABLE TO RETURN FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 06/18/2019: THE REP REPORTED THAT THE SURGEON DOES NOT CURRENTLY PLAN ON PERFORMING A SECOND SURGERY. THEY WILL CONTINUE TO MONITOR. A COPY OF THE X-RAY HAS BEEN PROVIDED TO ARTHREX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528486 DRILL BIT, 2.0MM (AO) BIT, DRILL HTW ARTHREX, INC. DRILL BIT, 2.0MM (AO) 031844 00888867052840

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other