BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 13CM

    MDR report key: 17839744 · Received September 28, 2023

    Report

    Report Number
    1220246-2023-08024
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 30, 2023
    Report Date
    October 21, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043756
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 ALLEGATION IS NOT CONFIRMED. VISUAL EVALUATION IDENTIFIED THAT THE DEVICE RETURNED IS NOT THE SAME AS THE ALLEGATION REPORTED. THE CUSTOMER RETURNED THE WRONG DEVICE, AND THE INVESTIGATION CANNOT BE PERFORMED. FUNCTIONAL TESTING WAS NOT PERFORMED BECAUSE THE WRONG DEVICE WAS RETURNED. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE LITTLE PLASTIC/ACRYLIC PIECE DETACHED FROM THE BURR AND STAYED INSIDE OF THE PATIENT. 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
    2157301 BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 13CM BURR,SURGICAL GFF ARTHREX, INC. BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 13CM 15061514 00888867043756

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown