BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR, ROUND, 8 FLUTE 5.0MM X 13VM

    MDR report key: 17555934 · Received August 16, 2023

    Report

    Report Number
    1220246-2023-07510
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 18, 2023
    Report Date
    December 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043879
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    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.

    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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A MANUFACTURING ISSUE. NCR-24360 HAS BEEN OPEN TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500RBE BURR, ROUND, 8 FLUTE 5.0MM X HAD AN ISSUE. AFTER A FEW MINUTES OF USING THE DEVICE, THE SURGEON NOTICED IT WAS NOT WORKING PROPERLY. THE SURGEON TOOK THE DEVICE OUT OF THE PATIENT AND THEN OFF THE HANDPIECE AND SAW THAT THE BOTTOM PLASTIC HAD BROKEN OFF AND HAD FALLEN OUT OF THE HANDPIECE. THE BURR WAS THEN DISPOSED OF, AND ANOTHER BURR WAS OPENED TO COMPLETE THE CASE WITHOUT HARMING THE PATIENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023, WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING A SUBACROMIAL DECOMPRESSION ON (B)(6) 2023. THE CASE WAS DELAYED FOR NO LONGER THAN 60 SECONDS AND ALL FRAGMENTS WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981989 BURR, ROUND, 8 FLUTE 5.0MM X 13VM BURR,SURGICAL GFF ARTHREX, INC. BURR, ROUND, 8 FLUTE 5.0MM X 13VM 15046356 00888867043879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown