BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, AO, Ø1.7MM

    MDR report key: 19505494 · Received June 10, 2024

    Report

    Report Number
    1220246-2024-05494
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 11, 2023
    Report Date
    June 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867316294
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT ALLEGATION CANNOT BE CONFIRMED WITHOUT THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO PHOTOS OF THE FAILURE WERE PROVIDED. PER THE EVENT DESCRIPTION, THE MOST LIKELY CAUSE(S) OF THE REPORTED FAILURE ARE USER ERROR, MISALIGNED INSERTION, AND PRYING/LEVERAGING THE DEVICE.

    Description of Event or Problem · 0

    ON 5/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-57 2.4MM DEPTH DRILL GUIDE AND AN AR-18700-58 1.7MM DRILL BIT ARE HAVING AN ISSUE. THE DRILL BIT THREADS CAUGHT ON THE DRILL GUIDE AND TWISTED INSIDE. THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7807 DRILL BIT, AO, Ø1.7MM DRILL BIT HTW ARTHREX, INC. DRILL BIT, AO, Ø1.7MM UNK 00888867316294

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown