BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BB-TAK, SMALL

    MDR report key: 15794062 · Received November 14, 2022

    Report

    Report Number
    1220246-2022-05752
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 14, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867312784
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-18700-34 BB-TAK, AND A AR-18700-89 DRILL BIT BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A CUNIEFORM FX WHEN THE SURGEON WAS USING A 1.6 CAGE PLATE OUT OF THE MINIFRAG FOR A MEDIAL CUNIEFORM FX. SHE WAS DRILLING WITH THE 1.2 DRILL BIT WITH THE VARIABLE ANGLE GUIDE AND THE DRILL BIT BROKE OFF INTO THE PATIENT. SHE WAS ABLE TO RETRIEVE THE FRAGMENT. AFTER THAT THEY SWITCHED TO THE SHORT 1.2 DRILL BIT AND STILL USED THE VARIABLE ANGLE GUIDE. ALL WAS GOING WELL UNTIL DRILLING FOR THE VERY LAST SCREW. THE 1.2 SHORT DRILL BROKE ALSO. ALL FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211609 BB-TAK, SMALL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. BB-TAK, SMALL 00888867312784

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown