BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX CANNULATED LAG SCREW

    MDR report key: 3873765 · Received April 22, 2014

    Report

    Report Number
    1051526-2014-00002
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 10, 2014
    Manufacturer
    VILEX, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VILEX WAS NOTIFIED ON (B)(4) 2014 BY AN ACCOUNT MANAGER THAT THE THREAD FROM A 3.5MM X 24MM TITANIUM SCREW BROKE WHILE BEING DRIVEN TO BONE. ACCOUNT MANAGER STATED THAT A KWIRE WAS INSERTED, COUNTERSINK WAS COMPLETED. HOWEVER, THERE WAS NO PRE-DRILLING. AFTER COUNTERSINKING, THE DOCTOR ATTEMPTED TO DRIVE THE SCREW INTO THE BONE AND THE PROXIMAL THREAD ON THE SCREW BROKE. ACCOUNT MANAGER ALSO STATED WHEN THE KWIRE WAS REMOVED, IT WAS NOT BENT. THE DOCTOR ALSO STATED THERE WAS DIFFICULTY IN CUTTING THE BONE DUE TO THE HARDNESS OF THE BONE. THE DOCTOR COMPLETED THE SURGERY WITHOUT ISSUE AND USED ANOTHER SCREW FROM THE VILEX SET. VILEX WAS NOT ABLE TO EVALUATE THE DEVICE AS THE FACILITY DISCARDED THE SCREW AND WIRE. THEREFORE, VILEX IS UNABLE TO DETERMINE THE EXACT CAUSE OF THE PRODUCT MALFUNCTION. A REVIEW OF COMPLAINTS WAS CONDUCTED AND NO OTHER COMPLAINTS HAVE BEEN FILED AGAINST THIS SCREW TYPE HAS BEEN RECEIVED. A VILEX ENGINEER ATTEND THE NEXT SCHEDULED SURGERY TO VERIFY THAT THE DOCTOR'S WERE USING THE RECOMMENDED PROCEDURE FOR VILEX SCREWS. DURING THE SURGERY, THERE WERE NO ISSUES.

    Description of Event or Problem · 1

    RECEIVED CALL FROM ACCOUNT MANAGER THAT THE SCREW THREAD BROKE WHILE BEING DRIVEN INTO THE 1ST METATARSAL DURING A BUNION OSTEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243076 VILEX CANNULATED LAG SCREW LAG SCREW TITANIUM HWC VILEX, INC. S35-24T-11 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1