BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM DRILL GUIDE

    MDR report key: 22097698 · Received May 28, 2025

    Report

    Report Number
    1220246-2025-02260
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 2, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00848665030082
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: D9, G3, H3, H6. ONE UNPACKAGED 0349-100 2.8MM DRILL GUIDE BATCH NUMBER: 230534 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED SIGNIFICANT DAMAGE TO THE DEVICE WITH SUPERFICIAL SCRATCHES AND INDENTATIONS OBSERVED. IT WAS FURTHER NOTED THAT AN 4040-000 CALIBRATED DRILL WAS STUCK WITH IN IT. THE MOST LIKELY CAUSE FOR THE OBSERVED DAMAGE CAN BE ATTRIBUTED TO MISUSE DUE TO MISHANDLING/USE ERROR. THE MOST LIKELY CAUSE FOR THE STUCK 4040-000 CALIBRATED DRILL CAN BE ATTRIBUTED TO USER ERROR DUE TO PRYING/LEVERAGING OF THE MATING INSTRUMENT WITHIN THE CANNULATION OF THE 0349-100 2.8MM DRILL GUIDE. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON 05/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0349-100 2.8MM DRILL GUIDE AND A 4040-000 CALIBRATED DRILL WERE BOTH DAMAGED. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358913 2.8MM DRILL GUIDE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 2.8MM DRILL GUIDE 230534 00848665030082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown