BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISSECTOR, 4.0MM X 13CM

    MDR report key: 2221196 · Received August 24, 2011

    Report

    Report Number
    1220246-2011-00141
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    April 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    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

    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 RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. EVALUATION REVEALED A BROKEN TIP ON THE OUTER SHAFT. FURTHER INVESTIGATION ALSO REVEALED BENT OUTER SHAFT AS WELL AS METAL GOUGING ON THE SURFACE OF THE INNER SHAFT AT THE DISTAL END WITH EVIDENCE OF WELD PENETRATION THROUGHOUT THE DEVICE. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. COMPLAINANT'S EVENT TYPICALLY CAUSED BY EXCESSIVE BENDING AND LEVERAGING FORCES ON THE DEVICE DURING USE. THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE CAUSE(S) OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE OUTER TUBE BROKE OFF DURING KNEE ARTHROSCOPY. THE PIECE WAS RETRIEVED BUT IN ORDER TO REMOVE THE BROKEN PIECE FROM THE PATIENT THE INCISION HAD TO BE ENLARGED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISSECTOR, 4.0MM X 13CM BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA ARTHREX, INC. 355828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other