BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, 2.75MM, .066 CANNULATION

    MDR report key: 22469286 · Received July 10, 2025

    Report

    Report Number
    1220246-2025-02832
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 27, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867040908
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE REPORTED EVENT IS CONFIRMED. THE VISUAL EVALUATION OF THE RECEIVED AR-7000-14, BATCH 022448 REVEALED THAT THE SHAFT IS BROKEN (SEE EVALUATION PICTURES 1 - 3). THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION, PRYING, AND LEVERAGING THE DEVICE.

    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 THE 2.75 MM DRILL WAS WORN OUT AND BROKEN. IN THE DISCARDED LEFTOVERS FROM THE SURGERY THE BROKEN PIECES WERE FOUND. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THIS WAS NOTICED DURING INCOMING INSPECTION. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE (B)(6) 06-JUN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED DEVICE BROKE DURING THE SURGERY. THE BROKEN PART WAS REMOVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH 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
    1728989 DRILL, 2.75MM, .066 CANNULATION MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. DRILL, 2.75MM, .066 CANNULATION 022428 00888867040908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown