BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM DRILL BIT

    MDR report key: 22675791 · Received July 31, 2025

    Report

    Report Number
    1220246-2025-03168
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 9, 2025
    Report Date
    September 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867298576
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. ONE UNPACKAGED, AR-9628, 3.0 MM DRILL BIT, BATCH NUMBER 022108, WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS BROKEN. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO EXCESSIVE USER-APPLIED MECHANICAL FORCES. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 07/09/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9628 3.0 MM DRILL BIT BROKE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE WHEN THE DRILL BIT BROKE OFF IN THE PATIENT WHILE DRILLING FOR PERIPHERAL SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160661 3.0MM DRILL BIT ORTHOPEDIC MANUAL SURG INSTR HTW ARTHREX, INC. 3.0MM DRILL BIT 022108 00888867298576

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown