BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURR, OVAL,SJ, 10 FLUTE, 3.0MM X 7CM

    MDR report key: 3881067 · Received June 18, 2014

    Report

    Report Number
    1220246-2014-00096
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    PMA / PMN Number
    AR-7300OBT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINANT'S EVENT TYPICALLY CAUSED BY USER MECHANICAL DAMAGE TO DEVICE SUCH AS HITTING THE DEVICE WITH ANOTHER DEVICE OR EXCESSIVE BENDING FORCES BEING APPLIED DURING USE. THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REALIZED THE BURR WAS NOT SPINNING ANY LONGER, SO HE REMOVED IT FROM THE PATIENT. THE SCRUB TECHNICIAN EXAMINED THE BURR AND REALIZED THE TIP WAS BROKEN OFF. THE SURGEON PERFORMED AN X-RAY AND THE RESULTS REVEALED THAT THE TIP OF THE BURR WAS STILL IN THE PATIENT. THE SURGEON THEN HAD TO MAKE ANOTHER INCISION TO RETRIEVE THE BROKEN TIP. THE RETRIEVAL OF THE BROKEN PIECE WAS COMPLETED BEFORE THE CASE WAS COMPLETED. CASE: LEFT WRIST ARTHROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357422 BURR, OVAL,SJ, 10 FLUTE, 3.0MM X 7CM BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF ARTHREX, INC. 423137

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other