BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM

    MDR report key: 17731286 · Received September 12, 2023

    Report

    Report Number
    1220246-2023-07860
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 17, 2023
    Report Date
    June 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043831
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-8500FOS SERIAL/BATCH NUMBER 15012073 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE OUTER TUBE HOOD WAS BENT INSIDE THE CUTTING BLADES. THE MOST LIKELY CAUSE(S) FOR THE REPORTED FAILURE CAN BE A USER ERROR DUE TO IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND/OR PRYING/LEVERING THE DEVICE DURING INSERTION. ACCORDING TO DFU-0215-EOR1-F. PRECAUTIONS. 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

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500FOS BURR GOT TWISTED AND IN THE HOOD, CAUSING METAL SHAVINGS ON THE LENS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104634 BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM BURR,SURGICAL GFF ARTHREX, INC. BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM 15012073 00888867043831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown