BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEARCUT SLAP BURR, 6 FLUTE , 3.85 MM X 12.5 CM

    MDR report key: 1182383 · Received September 30, 2008

    Report

    Report Number
    1220246-2008-00195
    Event Type
    Other
    Date Received
    September 30, 2008
    Date of Event
    July 22, 2008
    Report Date
    September 1, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THE PLASTIC BURR GUARD BREAKING IS EXCESSIVE BENDING FORCES APPLIED TO THE DEVICE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED FROM THE EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON WAS PERFORMING AN ACROMIOPLASTY WHEN THE TIP OF THE BURR BROKE OFF INSIDE THE JOINT. X-RAYS WERE REQUESTED TO FIND THE TIP. THE TIP WAS RETRIEVED AND THERE WAS NO PATIENT INJURY, BUT A SURGICAL DELAY OF MORE THAN A THIRTY MINUTES OCCURRED OF THE EVENT. NO FURTHER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARCUT SLAP BURR, 6 FLUTE , 3.85 MM X 12.5 CM GFF ARTHREX, INC. NA 131567

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INFORMATION REQUESTED BUT NOT PROVIDED