BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX HEMI IMPLANT

    MDR report key: 7301590 · Received February 27, 2018

    Report

    Report Number
    1051526-2018-00001
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 22, 2018
    Report Date
    January 31, 2018
    Manufacturer
    VILEX IN TENNESSEE, INC.
    Product Code
    KWD
    UDI-DI
    00841731106179
    PMA / PMN Number
    K102401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED CALL ON (B)(6) 2018 FROM ACCOUNT MANAGER THAT THE WIRE COULD NOT BE REMOVED FROM AN IMPLANT. FOLLOWING SURGICAL TECHNIQUE SURGEON INSERTED THE GUIDEWIRE AND USED TRIAL SIZER TO DETERMINE CORRECT SIZE OF THE IMPLANT NEED. SIZE WAS DETERMINED. SURGEON SLID THE IMPLANT OVER THE GUIDEWIRE AND BEGAN ADVANCING THE IMPLANT. BEFORE COMPLETELY TIGHTEN THE SURGEON REMOVED THE DRIVER AND ATTEMPTED TO REMOVE THE GUIDEWIRE. SURGEON TRIED REMOVING THE WIRE BY HOLDING DOWN ON THE IMPLANT WHILE PULLING THE WIRE. WHILE DOING SO, HE PULLED THE IMPLANT OUT OF THE CANAL. ONCE REMOVED SURGICAL TECH TRIED TO REMOVE THE WIRE FROM THE IMPLANT AND WAS UNSUCCESSFUL. IMPLANT-WIRE WERE CLEANED AND RETURNED TO VILEX. JANUARY 24, 2018, VILEX RECEIVED THE IMPLANT-WIRE FROM THE ACCOUNT MANAGER. JANUARY 31, 2018, VILEX'S QUALITY DEPARTMENT EXAMINED THE IMPLANT-WIRE. THE WIRE WAS FOUND TO BE STUCK AT THE INSERTION TIP. QUALITY PERSONNEL WAS ABLE TO REMOVE THE WIRE FROM THE IMPLANT. WIRE SIZE WAS CHECKED AND FOUND TO BE 1.6MM. IMPLANT CANNULATION WAS CHECKED WITH A 1.6MM GAGE PIN. NO PROBLEM WAS FOUND. UPON EXAMINING THE WIRE, HE FOUND IT TO BE BENT. WIRE ALSO HAD NICKS WHICH COULD HAVE POSSIBLY BEEN FROM THE WIRE DRIVER USED DURING SURGERY. IT IS BELIEVED THE SURGEON DID NOT PREDRILL THE CANAL AS HE STATED HE INSERTED THE WIRE AND STARTED DRIVING THE IMPLANT. AS WITH ANY CANNULATED IMPLANT, THE CANNULATION AND THE WIRE SIZE DEPENDS ON THE WIRE BEING STRAIGHT AND THE CANNULATION OF THE IMPLANT SLIDING FREELY OVER THE WIRE. IF THE WIRE IS BENT DURING INSERTION, THE IMPLANT CANNOT SLIDE OVER THE BEND IN THE WIRE AND WILL BECOME GALLED TO THE IMPLANT. IF MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    RECEIVED CALL ON (B)(6) 2018 FROM ACCOUNT MANAGER THAT SURGEON HAD AN ISSUE REMOVING THE GUIDEWIRE FROM THE IMPLANT ONCE IT WAS PARTIALLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144546 VILEX HEMI IMPLANT CHI IMPLANT KWD VILEX IN TENNESSEE, INC. CHI-2CH 5269 00841731106179

    Patients

    Seq Age Sex Outcome Treatment
    1