BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX/IMPLANTS

    MDR report key: 1686634 · Received May 13, 2010

    Report

    Report Number
    1219602-2010-00142
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 13, 2010
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV. IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC, ENDOSCOPY DIVISION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC, ENDOSCOPY DIVISION, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC. ENDOSCOPY DIV., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. (B) (4).

    Description of Event or Problem · 1

    DR. FORGOT TO CLICK T2; NOT USED TO IT. SALES REP. SAID THAT FORGETTING TO CLICK T2 IS SIMPLY BECAUSE THE SURGEON IS STILL ON AUTOPILOT WITH HOW TO DELIVER T2 IN THE OLD FAST-FIX. THERE WILL BE A LEARNING CURVE WITH SOME SURGEONS. IN THIS CASE, DR. CUT THE SUTURE FREE AND LEFT T2 IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-FIX/IMPLANTS FAST-FIX 360 CURVED NEEDLE DELIVERY SYST GAT MANSFIELD MANUFACTURING SITE 72202468 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1