BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, AO, Ø1.7MM

    MDR report key: 17481668 · Received August 8, 2023

    Report

    Report Number
    1220246-2023-07454
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 10, 2023
    Report Date
    October 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867316294
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: COMPLAINT ALLEGATION IS CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A USER ERROR OF THE DEVICE DUE TO MISALIGNMENT INSERTION, AND/OR PRYING/LEVERAGING OF THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 7/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-58 DRILL BIT BROKE IN HALF INSIDE THE PATIENT'S FOOT. THIS WAS DISCOVERED DURING A SECOND METATARSAL NON-UNION PROCEDURE ON (B)(6) 2023. THE BROKEN FRAGMENT WAS FULLY RETRIEVED, AND THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968167 DRILL BIT, AO, Ø1.7MM DRILL BIT HTW ARTHREX, INC. DRILL BIT, AO, Ø1.7MM 1392253 00888867316294

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown