BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX 3.0MM CANNULATED SCREW

    MDR report key: 2850423 · Received November 26, 2012

    Report

    Report Number
    1051526-2012-00004
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 20, 2012
    Manufacturer
    VILEX, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR WAS PERFORMING AUSTIN BUNIONECTOMY IN THE PATIENTS LEFT FOOT. THE SCREW WOULD NOT TIGHTEN AND WHEN HE REMOVED IT, ONE OF THE SCREW TIPS HAD BROKEN AND ANOTHER HAD ENT. THE DOCTOR CHOSE ANOTHER SCREW FROM THE VILEX SCREW SET AND THE SURGERY WAS COMPLETED WITHOUT ANY ISSUES. THE DOCTOR DID A POST-OP X-RAY AND DETERMINED THAT NO METAL PIECES FROM THE FIRST SCREW REMAINED IN THE PATIENT'S FOOT. THE FACILITY WAS ABLE TO RETURN THE SCREW TO VILEX. THE SCREW WAS EVALUATED BY VILEX'S QUALITY DEPARTMENT AND IT WAS DETERMINED THAT THE SCREW CAME IN CONTACT WITH A BENT K-WIRE OR OTHER METAL IMPLANT ALREADY IN THE BONE. VILEX WAS NOT ABLE TO EVALUATE THE K-WIRE USED, AS THE FACILITY DID NOT RETURN IT . WITHOUT THE K-WIRE, NO FURTHER EVALUATION IS POSSIBLE. ALL OTHER SCREWS OF THIS SAME LOT HAVE BEEN IMPLANTED WITHOUT ANY ISSUES. ON (B)(6)-2012, A LETTER WAS SENT TO THE CUSTOMER EXPLAINING WHAT MAY HAVE CAUSED THE SCREW TIPS TO BREAK AND BEND. THE CUSTOMER WAS GIVEN A COPY OF VILEX'S INSTRUCTION FOR USE.

    Description of Event or Problem · 1

    VILEX RECEIVED REPORT FROM FACILITY THAT A SCREW TIP BROKE AND ANOTHER TIP FLARED OUT. THE DOCTOR IMPLANTED THE SCREW ACROSS AN OSTEOTOMY SITE. THE SCREW FAILED TO TIGHTEN. DOCTOR REMOVED THE SCREW AND NOTED IT TO HAVE ONE BROKEN TIP AND ANOTHER TIP THAT WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VILEX 3.0MM CANNULATED SCREW 3.0MM STAINLESS LAG SCREW HWC VILEX, INC. S30-14S-09 3871

    Patients

    Seq Age Sex Outcome Treatment
    1