BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALAXO 8X25 SCREW

    MDR report key: 731845 · Received June 23, 2006

    Report

    Report Number
    1219602-2006-00083
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 22, 2006
    Report Date
    June 21, 2006
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIVISION
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 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 TOTHE EVENT DESCRIBED IN THE REPORT. DEVICE IS NOT BEING RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT PROVIDING FIXATION.

    Description of Event or Problem · 1

    DURING AN ACL RECONSTRUCTION, THE SCREW CRACKED THE B-T-B GRAFT. SALES REPRESENTATIVE FOR SMITH+NEPHEW CONFIRMED THAT THE SURGEON TAPPED THE INSERTION SITE WITH OUR 9MM TAP FOR CALAXO SCREWS, INSERTED THE SCREW AND THE BONE BLOCK OF THE GRAFT CRACKED. THE SCREW AND GRAFT WERE LEFT IN PLACE AS FIXATION WAS ACHIEVED. NO DELAY TOOK PLACE AND NO PATIENT INJURY OR COMPLICATIONS RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO 8X25 SCREW CALAXO SCREW HWC SMITH & NEPHEW, INC., ENDOSCOPY DIVISION 7211116 50149640

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other
    2