BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY BONE SAW CAM ASSEMBLY 12MM

    MDR report key: 1718953 · Received June 11, 2010

    Report

    Report Number
    1825034-2010-00211
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 19, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE DEVICE FOUND POSITIVE MATERIAL IN THE INSIDE DIAMETER THAT WOULD PREVENT THE BONE SAW BLADE ASSEMBLY FROM BEING SUCCESSFULLY INSERTED IN THE CAM ASSEMBLY, THEREFORE NOT ALLOWING THE TWO COMPONENTS TO WORK TOGETHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING AN INTRAMEDULLARY BONE SAW CAM ASSEMBLY ON (B) (6) 2010. DURING THE PROCEDURE, THE BONE SAW BLADE COULD NOT BE INSERTED INTO THE BONE SAW CAM ASSEMBLY SUCCESSFULLY. THE SURGEON HAD TO COMPLETE THE PROCEDURE USING A DIFFERENT OSTEOTOMY TECHNIQUE. THERE WAS A DELAY OF GREATER THAN THIRTY MINUTES TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMEDULLARY BONE SAW CAM ASSEMBLY 12MM BLADE, SAW, GENERAL SURGERY GFA BIOMET ORTHOPEDICS N/A 130340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R