BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRACTABLE CANNULATED KNIFE, STRAIGHT

    MDR report key: 3122015 · Received May 21, 2013

    Report

    Report Number
    1220246-2013-00082
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 25, 2013
    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

    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 RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. EVALUATION REVEALED THAT THE RETRACTABLE HIP BLADE BENT AND THE DISTAL END OF THE TUBE BROKE OFF AT THE WELD LOCATION. COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY USER MECHANICAL DAMAGE SUCH AS HITTING THE DEVICE WITH ANOTHER DEVICE AND THE USE OF EXCESSIVE BENDING FORCE. 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 ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROTECTION COVER AT THE TIP BROKE OFF WITHOUT ANY FORCE. THE INCISION HAD TO BE ENLARGED FOR THE BROKEN PIECE TO BE RETRIEVED COMPLETELY AND SURGERY COMPLETED SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225065 RETRACTABLE CANNULATED KNIFE, STRAIGHT BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA ARTHREX, INC. 496748

    Patients

    Seq Age Sex Outcome Treatment
    1 Other