BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, 2.75MM, .066 CANNULATION

    MDR report key: 23043911 · Received September 12, 2025

    Report

    Report Number
    1220246-2025-03847
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 25, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867040908
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. - ONE UNPACKAGED AR-7000-14, DRILL, 2.75MM, .066 CANNULATION, BATCH NUMBER 022448, WAS RECEIVED FOR INVESTIGATION. - UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE SHAFT OF THE DRILL IS BROKEN OFF PARTLY. - FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. - THE BROKEN OFF FRAGMENT WAS RETURNED FOR EVALUATION. - THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISALIGNED INSERTION AND/OR PRYING AND LEVERAGING THE DEVICE WITH EXCESSIVE FORCE. - REFER TO EVALUATION PICTURES. - THE COMPLAINT ALLEGATION IS CONFIRMED.

    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

    IT WAS REPORTED THAT DURING A LATERJET SURGERY THE DRILL BROKE OFF AT THE ATTACHMENT. 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
    2170948 DRILL, 2.75MM, .066 CANNULATION MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. DRILL, 2.75MM, .066 CANNULATION 022448 00888867040908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown