BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, 2.75MM, .066 CANNULATION

    MDR report key: 23392781 · Received October 27, 2025

    Report

    Report Number
    1220246-2025-04843
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 22, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867040908
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 COMPLAINT ALLEGATION IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE OF A DAMAGED AR-7000-14 DRILL, BATCH 022516, IN WHICH THE DISTAL TIP APPEARS FRACTURED. BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, THE EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO OFF-AXIS ENGAGEMENT AND PRYING OR LEVERAGING OF THE DEVICE WITH EXCESSIVE FORCE DURING DRILLING, RESULTING IN MECHANICAL OVERSTRESS AND TIP FRACTURE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-7000-14, DRILL, 2.75 MM, 0.066'' CANNULATION, THE LONG 2.75 MM CANNULATED DRILL TIP SHATTERED IN FRAGMENTS INSIDE PATIENT AFTER INSERTING GUIDE WIRES. THIS WAS DETECTED DURING USE IN A CONGRUENT-ARC LATARJET PROCEDURE USING THE GLENOID BONE LOSS SET WITH 3.75 MM CANNULATED SCREWS ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS X-RAYS WERE CALLED IN TO IDENTIFY AND REMOVE FRAGMENTS OF DEVICE INSIDE THE PATIENT, AND AN ALTERNATIVE 2.75MM CANNULATED SCREW USED IN PLACE. 2 FRAGMENTS UNABLE TO BE RETRIEVED IN PATIENT, BUT SURGEONS' CLINICAL JUDGEMENT WAS TO LEAVE AS IT IS INSIDE THE BONE AND WON'T CAUSE ANY ISSUES WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734111 DRILL, 2.75MM, .066 CANNULATION MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. DRILL, 2.75MM, .066 CANNULATION UNK 00888867040908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown