BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM DRILL BIT

    MDR report key: 11046716 · Received December 21, 2020

    Report

    Report Number
    1220246-2020-02423
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    December 3, 2020
    Report Date
    January 8, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, AN APPROXIMATELY 1 IN LONG FRAGMENT OF THE DRILL FLUTED TIP BROKE OFF FROM THE DEVICE. CIRCUMFERENTIAL SCUFF MARKS WERE OBSERVED AROUND THE OD OF THE FLUTE NEAR THE BREAKAGE. THE CAUSE IS UNDETERMINED, HOWEVER LIKELY CAUSES INCLUDE PRYING/LEVERING THE DEVICE DURING USE.

    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 THAT DURING A (B)(6) 2020 REVERSE TOTAL SHOULDER ARTHROSCOPY CASE, THE AR-9628 DRILL BIT (LOT 022030) BROKE WHILE DRILLING IN THE GLENOID. THE DRILL WAS USED WITH THE NON-LOCKING DRILL SLEEVE INTO A 24 +4 LATERAL BASEPLATE WITH A 25MM CENTRAL SCREW. THE BONE QUALITY WAS GOOD-HARD BUT NOT VERY HARD. THE DRILL BIT BROKE OFF AND REMAINED IN THE BONE. ABOUT 30MM OF THE DRILL BIT WAS LEFT BEHIND IN THE GLENOID. THIS WAS NOT BICORTICAL AND STILL CONTAINED WITHIN THE GLENOID/SCAPULA. THE DRILL FRAGMENT WAS LEFT IN AND WAS RECESSED BELOW THE BONE CORTEX/GLENOID SURFACE. THEY WERE UNABLE TO RETRIEVE THE BROKEN PART OF THE DRILL BIT AS IT WOULD HAVE REQUIRED THE SURGEON TO REMOVE THE BASEPLATE TO DO SO. THE SURGEON DIDN'T WANT TO COMPROMISE THE GOOD BASEPLATE FIXATION THAT WAS ACHIEVED. SURGEON ELECTED TO LEAVE THE DRILL BIT IN THE PATIENT. NO HARM WAS CAUSED (DEEMED BY THE SURGEON). ANOTHER DRILL WAS USED TO COMPLETE THE IMPLANTATION OF THE REMAINING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514975 3.0MM DRILL BIT BIT, DRILL HTW ARTHREX, INC. 3.0MM DRILL BIT 022030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other