BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR,RND,CLEARCUT,8 FLUT,5.5MMX 13CM

    MDR report key: 23236187 · Received October 7, 2025

    Report

    Report Number
    1220246-2025-04483
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    July 2, 2025
    Report Date
    October 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-8550CRE BATCH 15326989 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE MOLDED CLEAR TIP WAS NOT ASSEMBLED ONTO THE SHAFT TIP, MOST LIKELY DUE TO BREAKAGE. SCRATCHES AND DENTS WERE OBSERVED ON THE CUTTING TIP OF THE OUTER SHAFT, LIKELY CAUSED BY EXCESSIVE FORCE. FUNCTIONAL TESTING WAS PERFORMED BY ROTATING THE INNER AND OUTER SHAFTS; NO RESISTANCE WAS NOTED. THE INNER SHAFT WAS REMOVED, AND BROWN MARKS WERE OBSERVED, POSSIBLY INDICATING INSUFFICIENT IRRIGATION. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS USER ERROR, INCLUDING EXCESSIVE SIDE LOADING ON THE DEVICE DURING USE. DIRECTIONS FOR USE. DFU-0215-EOR1_FMT_EN. DISPOSABLE ARTHROSCOPIC SHAVER BLADES, BURRS, POWERPICK¿, POWERASP¿, NANORESECTION¿, AND SHAVERDRILL¿ DEVICES. F. PRECAUTIONS, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THE BURR GOT STUCK IN THE GENERATOR. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 24-SEP-2025: THE DEVICE WAS RETURNED TO ARTHREX INC FOR INVESTIGATION. DURING INVESTIGATION IT WAS NOTED THAT THE CLEAR TIP OF THE RECEIVED DEVICE WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487539 BUR,RND,CLEARCUT,8 FLUT,5.5MMX 13CM BURR,SURGICAL GFF ARTHREX, INC. BUR,RND,CLEARCUT,8 FLUT,5.5MMX 13CM 15326989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown