BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR, OVAL, 8 FLUTE 4.0MM X 13CM

    MDR report key: 23907104 · Received December 29, 2025

    Report

    Report Number
    1220246-2025-05865
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 29, 2025
    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

    THE COMPLAINT ALLEGATION IS CONFIRMED. BASED ON PHOTOGRAPHIC EVIDENCE, THE AR-8400OBE BURR (BATCH 15496415) WAS DAMAGED AT THE DISTAL HUB. AFTER REVIEWING THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER ERROR, RESULTING FROM IMPROPER ENGAGEMENT OR MISALIGNMENT DURING BURR INSERTION, WHICH LED TO EXCESSIVE STRESS ON THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULA (AC) DECOMPRESSION SURGERY THE SHAVER HANDPIECE AR-8332H (SN (B)(6) DAMAGED THE BURR AR-8400OBE (LOT: 15496415). THE BURR GOT TORN UP IN THE BOTTOM WHERE IT WAS CONNECT TO THE SHAVER. PLASTIC PIECES REMAINED IN THE SHAFT OF THE 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
    2847167 BURR, OVAL, 8 FLUTE 4.0MM X 13CM BURR,SURGICAL GFF ARTHREX, INC. BURR, OVAL, 8 FLUTE 4.0MM X 13CM 15496415 00888867043602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown