BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAS T -FIX AB CURVED NEEDLE DELIVERY SYSTEM

    MDR report key: 731829 · Received June 23, 2006

    Report

    Report Number
    1219602-2006-00084
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 17, 2006
    Report Date
    June 21, 2006
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIVISION
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC. ENDOSCOPY DIV. 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 DIV. OR ITS EMPOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, IC. ENDOSCOPY DIV. OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. DEVICES ARE NOT BEING RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED DEVICE FAILURE.

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR, T2 WOULD NOT DEPLOY. ORTHO COORDINATOR CONFIRMED THAT THE SURGEON WAS PERFORMING A MENISCAL REPAIR AND HAD DIFFICULTY ADVANCING T2 INTO DEPLOYMENT POSITION. WHEN T2 WAS FINALLY ADVANCED IT WOULD NOT DEPLOY. THIS OCCURRED WITH FOUR DEVICES FROM THE SAME LOT. THE REPAIR WAS COMPLETED WITH ADDITIONAL FAS T - FIX AB OF OTHER LOTS. THE SURGEON REMOVED TWO OF THE FOUR T1 S THAT WERE IMPLANTED. COORDINATOR REMARKED THAT THE TRIGGER DID NOT SNAP DURING THE ADVANCEMENT OF T2 AS THEY NORMALLY DO. A DELAY OF FIVE MINUTES RESULTED. NO PATIENT INJURY OR COMPLICATIONS TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAS T -FIX AB CURVED NEEDLE DELIVERY SYSTEM FAST -FIX AB MBI SMITH & NEPHEW, INC., ENDOSCOPY DIVISION 7209399 50161408

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other