BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25MM TAP

    MDR report key: 23136566 · Received September 24, 2025

    Report

    Report Number
    1220246-2025-04127
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED, AR-9621-25T, 25 MM TAP WITH BATCH 022420, WAS RECEIVED FOR INVESTIGATION AND THE EVALUATION REVEALED THAT THE TIP OF THE CUTTING FLUTE WAS BROKEN OFF (SEE EVALUATION PICTURE 3). NO FRAGMENTS WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISALIGNED INSERTION; AND PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE TOTAL SHOULDER REPLACEMENT SURGERY THAT THE TIP OF THE TAP BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. 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
    2493127 25MM TAP ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 25MM TAP 022420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown