BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR 2.9 SUTURE ANCHOR W/TWO SUTURES

    MDR report key: 727120 · Received June 19, 2006

    Report

    Report Number
    1219602-2006-00080
    Event Type
    Malfunction
    Date Received
    June 19, 2006
    Date of Event
    May 11, 2006
    Report Date
    June 15, 2006
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIV
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report

    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 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. NO PRODUCT IS BEING RETURNED FOR EVALUATION THEREFORE NO DETERMINATION COULD BE MADE FOR THE REPORTED DEVICE FAILURE. M-4559.

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC BANKART REPAIR OF THE RIGHT SHOULDER, SIX ANCHORS SPLIT/BROKE. AFTER EACH ANCHOR WAS TAPPED, IT SPLIT AT THE HEAD OF THE ANCHOR AND BROKE. A NEW HOLE WAS DRILLED EACH TIME. THE SALES REP, WHO ATTENDED THE CASE DID NOT OBSERVE ANY ERRORS WITH THE TECHNIQUE. THE GLENOID RIM OF THE PATIENT WAS DAMAGED IN THE PROCESS. THE SURGEON USED A COMPETITOR'S 3.5 ANCHOR TO COMPLETE THE REPAIR. A DELAY OF ONE HOUR TOOK PLACE. E-MAIL CONFIRMED THAT THE INSERTION LOCATIONS WERE DRILLED WITH A 3.0MM DRILL FOR BIORAPTOR ON A YOUNG MALE WITH HARD BONE. THE SURGEON WAS ABLE TO REMOVE SOME BUT NOT ALL OF THE ANCHORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIORAPTOR 2.9 SUTURE ANCHOR W/TWO SUTURES BIORAPTOR MBI SMITH & NEPHEW, INC., ENDOSCOPY DIV 7210706 50143112

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other