BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, .059" (1.5MM), AO

    MDR report key: 22665654 · Received July 30, 2025

    Report

    Report Number
    1220246-2025-03149
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 2, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867385504
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD INFORMATION, ARTHREX WAS ABLE TO DETERMINE THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND/OR PRYING OR LEVERING THE DEVICE DURING INSERTION, WHICH RESULTED IN THE DEVICE BREAKING. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H6.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 07/17/2025 WHERE IT WAS STATED THEY ARE USURE HOW THE DEVICE BROKE, POSSIBLY DURING DRILLING IT MAY HAVE HIT THE K-WIRE. THE PATIENT HAD A GOOD BONE QUALITY. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETE BEFORE THE BROKEN DRILL BIT WAS DISCOVERED. THERE WAS A 30 MINUTE DELAY THAT DID REQUIRE ADDITIONAL ANESTHESIA.

    Description of Event or Problem · 0

    ON 07/07/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-18800-01 DRILL BIT WAS NOTED INSIDE THE PATIENT. THIS OCCURRED DURING THE REMOVAL OF THE RIGHT FOOT EXTERNAL FIXATOR RIGHT FOURTH METATARSAL LENGTHENING WITH ALLOGRAFT PLACEMENT AND INTERNAL FIXATION, EXTENSOR DIGITORUM LONGUS TENDON LENGTHENING RIGHT FOOT, FOURTH METATARSAL PHALANGEAL JOINT CAPSULOTOMY RIGHT FOOT, TAILORS BUNION REPAIR WITH DISTAL FIFTH METATARSAL OSTEOTOMY AND SCREW FIXATION RIGHT FOOT ARTHREX CANNULATED BONE DOWEL REVISION ALLOGRAFT WHEN THE DRILL BIT WAS NOTED INSIDE THE INCISION WHEN THE FINAL X-RAY WAS TAKEN. THE FRAGMENT WAS APPROXIMATELY .5CM IN LENGTH. THE FRAGMENT WAS REMOVED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496278 DRILL BIT, .059" (1.5MM), AO DRILL BIT HTW ARTHREX, INC. DRILL BIT, .059" (1.5MM), AO 1392349 00888867385504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown