BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR,RND,SJ,8 FLUT 3.0MMX 7CM

    MDR report key: 23109896 · Received September 22, 2025

    Report

    Report Number
    1220246-2025-04003
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    July 28, 2025
    Report Date
    January 19, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO MISALIGNED INSERTION AS INDICATED ON DFU-0215-EO. 6. DO NOT ALLOW THE ROTATING PORTION OF ANY DEVICE TO TOUCH ANY METALLIC OBJECT, SUCH AS A CANNULA OR ARTHROSCOPE, DURING USE. DAMAGE TO BOTH DEVICES IS LIKELY. DAMAGE TO THE DEVICE CAN RANGE FROM A SLIGHT DISTORTION OR DULLING OF THE BLADE/BURR EDGE TO ACTUAL FRACTURE OF THE TIP IN VIVO. IF SUCH CONTACT DOES OCCUR, INSPECT THE TIP. IF THERE ARE CRACKS, FRACTURES OR DULLING, OR IF THERE IS ANY OTHER REASON TO SUSPECT A BLADE IS DAMAGED, REPLACE IT IMMEDIATELY. 7. EXCESSIVE "SIDE-LOADING" ON THE DEVICE DURING USE DOES NOT IMPROVE CUTTING PERFORMANCE AND IN EXTREME CASES WILL CAUSE IRREVERSIBLE DAMAGE TO 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

    ON 09/03/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-7300RBE 8-FLUTE 3.0MM X 7CM ROUND BURR RAZOR BLADE JAMMED AND BROKE DURING A CASE WITH NO PATIENT AFFECTED. A NEW ONE WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171224 BUR,RND,SJ,8 FLUT 3.0MMX 7CM BURR,SURGICAL GFF ARTHREX, INC. BUR,RND,SJ,8 FLUT 3.0MMX 7CM 15196097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown