BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURR, OVAL, 8 FLUTE 4.0MM X 13CM

    MDR report key: 7933610 · Received October 4, 2018

    Report

    Report Number
    1220246-2018-00687
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    September 13, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867043602
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. THE EVALUATION REVEALED METAL SCUFFING ON THE ID OF THE OUTER TUBE AND ON THE COLLAR OF THE INNER TUBE OF THE AR-8400OBE, TYPICALLY CAUSED BY EXCESSIVE BENDING FORCES APPLIED TO THE DEVICE DURING USE. RUST AND METAL DISCOLORATION WERE OBSERVED ON THE INNER TUBE OF THE DEVICE, ADDITIONALLY. THIS TYPE OF DISCOLORATION IS TYPICALLY OBSERVED WHEN THE END USER DOES NOT HAVE FLUID OR HAS LOW FLUID FLOWING THROUGH THE DEVICE DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR AS THE SURGEON WAS BURRING, METAL SHAVINGS WERE FLAKING OFF OF THE AR-8400OBE, OVAL BURR 8 FLUTE. THE REP STATED THAT THERE WAS NOT AN ARTHREX REP PRESENT DURING THE PROCEDURE, AND IT IS UNKNOWN IF THE SHAVINGS WERE RETRIEVED OR BIG ENOUGH TO BE RETRIEVED. THE REP STATED THAT THE CASE WAS COMPLETED BY USING THE SAME AR-8400OBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777690 BURR, OVAL, 8 FLUTE 4.0MM X 13CM BURR, SURGICAL, GENERAL & PLASTIC SURGERY GFF ARTHREX, INC. BURR, OVAL, 8 FLUTE 4.0MM X 13CM UNK 00888867043602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other