BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, .059" (1.5MM)

    MDR report key: 18386212 · Received December 22, 2023

    Report

    Report Number
    1220246-2023-09605
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 28, 2023
    Report Date
    December 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867312708
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: B5, G3, H3, H6. COMPLAINT ALLEGATION IS NOT 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 11/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-18700-20 DRILL BIT BROKE AND COLD WELDED TO THE AR-18800-48 DRILL GUIDE. THIS OCCURRED DURING A CASE WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 12/12/2023 WHERE IT WAS STATED THAT THIS EVENT OCCURRED DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(6) 2023. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THEY UTILIZED A FREE NEEDLE AND ADDITIONAL ETHIBOND SUTURE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296927 DRILL BIT, .059" (1.5MM) DRILL BIT HTW ARTHREX, INC. DRILL BIT, .059" (1.5MM) 1392318 00888867312708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown