BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURR, OVAL, FLUSHCUT, 12 FLUTE, 5.0MM X 13CM

    MDR report key: 3801652 · Received May 9, 2014

    Report

    Report Number
    1220246-2014-00072
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 16, 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/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. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED THIS TYPE OF EVENT IS TYPICALLY CAUSED BY EXCESSIVE BENDING FORCES APPLIED TO THE DEVICE DURING USE. 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 DURING CLAVICULA RESECTION ON A MALE PATIENT WITH NORMAL BONE STRUCTURE THE BLADE WAS TWISTED WITHOUT ANY MAJOR OUTER FORCE. THE BLADE PROTECTING THE BORE CAME IN CONTACT WITH THE ROTATING BORE AND GOT TWISTED RESULTING IN SEVERE DEFORMITY OF THE SHAVER BLADE AND AN AMOUNT OF METAL DEBRIS INTRA-ARTICULARLY. FOLLOW-UP INFORMATION: THERE WERE TRACES OF DEBRIS IN THE JOINT AND THEY WERE ABLE TO FLUSH OUT MOST OF IT WITH THE DUALWAVE SYSTEM. THIS IS ALL THE NEW INFORMATION THAT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280122 BURR, OVAL, FLUSHCUT, 12 FLUTE, 5.0MM X 13CM BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other