BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY BONE SAW CAM ASSEMBLY 16MM

    MDR report key: 1713954 · Received June 8, 2010

    Report

    Report Number
    1825034-2010-00203
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 14, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW DETERMINED THE PART WAS ERRANTLY REPORTED AS THERE WAS NO POSITIVE MATERIAL IDENTIFIED. (B)(4)

    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 INTRAMEDULLARY BONE SAW CAM ASSEMBLIES ON (B) (6) 2010. DURING THE PROCEDURE, THE SIZE 15MM AND 16MM BONE SAW BLADES COULD NOT BE INSERTED INTO THE BONE SAW CAM ASSEMBLIES SUCCESSFULLY. THERE WAS A DELAY OF GREATER THAN THIRTY MINUTES TO THE PROCEDURE AS A RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING INTRAMEDULLARY BONE SAW CAM ASSEMBLIES ON (B)(6) 2010. DURING THE PROCEDURE, THE SIZE 15MM AND 16MM BONE SAW BLADES COULD NOT BE INSERTED INTO THE BONE SAW CAM ASSEMBLIES SUCCESSFULLY. 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 16MM BLADE, SAW, GENERAL SURGERY GFA BIOMET ORTHOPEDICS N/A 232620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R