BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR, OVAL, 8 FLUTE 5.0MM X 13CM

    MDR report key: 17767781 · Received September 18, 2023

    Report

    Report Number
    1220246-2023-07937
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 23, 2023
    Report Date
    August 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043862
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-8500OBE SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO DAMAGE TO THE DEVICE. VISUAL EVALUATION OF THE INNER TUBE FOUND THAT THE SHRINK TUBING WAS CRACKED/DAMAGED AT THE DISTAL AND PROXIMAL END; MOST LIKELY CAUSE FOR POOR FLOW IRRIGATION. ACCORDING TO DFU-0215-7 AT REVISION 0. 9. IRREVERSIBLE DAMAGE TO ALL DEVICES WILL RESULT IF THEY ARE RUN WITHOUT THE FLOW OF IRRIGATION (DRY).10. RUNNING THE DEVICE WITHOUT THE FLOW OF IRRIGATION (DRY) WILL CAUSE THE DEVICE TO EXCESSIVELY HEAT AND MAY CAUSE A THERMAL BURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHAVER ATTACHMENT IS DEFECTIVE. IT DOES NOT RUN SMOOTHLY AND IT COULD NOT BE USED ANYMORE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. ***UPDATE 29-AUG-2023 NROE: FURTHER INFORMATION REVEALED THAT THIS INCIDENT OCCURRED DURING AN ARTHROSCOPY. 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
    1948483 BURR, OVAL, 8 FLUTE 5.0MM X 13CM BURR,SURGICAL GFF ARTHREX, INC. BURR, OVAL, 8 FLUTE 5.0MM X 13CM 15040614 00888867043862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown