BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM DRILL BIT

    MDR report key: 22420904 · Received July 7, 2025

    Report

    Report Number
    1220246-2025-02758
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 10, 2025
    Report Date
    September 18, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867298576
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED, AR-9628, 3.0 MM DRILL BIT, BATCH NUMBER 022402, WAS RECEIVED FOR INVESTIGATION AND THE VISUAL EVALUATION REVEALED THAT THE TIP OF THE DEVICE WAS BROKEN AND THE SHAFT / THE THREAD WAS TWISTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY THE DEVICE BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176201 3.0MM DRILL BIT ORTHOPEDIC MANUAL SURG INSTR HTW ARTHREX, INC. 3.0MM DRILL BIT 022402 00888867298576

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown