BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURR, OVAL, 8 FLUTE 4.0MM X 13CM

    MDR report key: 3633501 · Received February 19, 2014

    Report

    Report Number
    1220246-2014-00013
    Event Type
    Injury
    Date Received
    February 19, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 23, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. 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. BASED ON THE INFORMATION PROVIDED, THIS TYPE OF EVENT IS TYPICALLY CAUSED BY EXCESSIVE BENDING FORCES APPLIED TO THE DEVICE DURING USE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE WAS DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACROMION SHAVING, THE BURR PRODUCED METAL DEBRIS WHICH WAS NOT FULLY REMOVED FROM PATIENT. SURGERY FINISHED SUCCESSFULLY. NO OTHER DETAILS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106120 BURR, OVAL, 8 FLUTE 4.0MM X 13CM BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF ARTHREX, INC. 947273

    Patients

    Seq Age Sex Outcome Treatment
    1 Other