BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR, OVAL, 8 FLUTE 4.0MM X 13CM

    MDR report key: 23479101 · Received November 5, 2025

    Report

    Report Number
    1220246-2025-05027
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 28, 2025
    Report Date
    January 2, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043602
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-8400OBE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE CONNECTOR HUB WAS BROKEN OFF. A FUNCTIONAL TEST CANNOT BE PERFORMED AS THE HUB WAS DAMAGED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A USER ERROR; SPECIFICALLY, INCORRECT SETTING OF THE DEVICE ON THE HANDPIECE OR USING THE INCORRECT HANDPIECE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER DECOMPRESSION SURGERY THE SHAVER HANDPIECE AR-8332H (SN: (B)(6)) DAMAGED 2 BURRS AR-8400OBE (BATCH 15446780). THEY GOT TORN UP IN THE BOTTOM WHERE THEY ATTACH TO SHAVER HANDPIECE. 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
    2692968 BURR, OVAL, 8 FLUTE 4.0MM X 13CM BURR,SURGICAL GFF ARTHREX, INC. BURR, OVAL, 8 FLUTE 4.0MM X 13CM 15446780 00888867043602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown