BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX

    MDR report key: 2607562 · Received June 4, 2012

    Report

    Report Number
    1051526-2012-00001
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Date of Event
    August 12, 2011
    Report Date
    June 1, 2012
    Manufacturer
    VILEX, INC.
    Product Code
    JDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR BENT OR SCORED THE K-WIRE, DURING INSERTION AND/OR REMOVAL. THE K-WIRE WAS INSERTED THE SECOND TIME AT AN ANGLE WHICH IS NOT RECOMMENDED. VILEX HAS USED THE SAME LOT NUMBER MATERIAL FOR TWO YEARS WITH NO PROBLEMS. DOCTOR REPORTED NO PROBLEM FOR PT.

    Description of Event or Problem · 1

    VILEX ACCOUNT MANAGER REPORTED THAT A K113-16S KWIRE BROKE AND APPROXIMATELY 3CM REMAINS IN THE PT. THE DOCTOR INSERTED THE WIRE INTO THE MEDULLARY CANAL, DID NOT LIKE THE POSITION OF THE WIRE AND REMOVED THE WIRE COMPLETELY. DOCTOR THEN REDIRECTED THE WIRE AT AN ANGLE AND IMPLANTED THE METATARSAL HEAD IMPLANT. WHILE REMOVING THE WIRE THE SECOND TIME WITH A WIRE DRIVER, THE WIRE TWISTED AND BROKE. DOCTOR STATED THAT APPROXIMATELY 3CM OF THE WIRE REMAINS IN THE PT . DOCTOR ALSO STATED THAT THERE WOULD BE NO PROBLEM FOR THE WIRE TO REMAIN IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VILEX K-WIRE JDW VILEX, INC. K113-16S

    Patients

    Seq Age Sex Outcome Treatment
    1