BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX 3.0MM DUAL THREAD "HEADLESS" SCREW

    MDR report key: 2857731 · Received November 15, 2012

    Report

    Report Number
    1051526-2012-00002
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    September 9, 2010
    Report Date
    November 13, 2012
    Manufacturer
    VILEX IN TENNESSEE, INC
    Product Code
    JDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER A REVIEW OF COMPLAINTS, IT WAS DETERMINED THAT A MDR SHOULD BE FILED ON THIS EVENT. VILEX HAD GENERATED A COMPLAINT, ACCORDING TO PROCEDURE, AT THE TIME THE EVENT WAS REPORTED, BUT FELT SINCE NO PART OF THE SCREW OR GUIDE WIRE WAS LEFT IN THE PT, A MDR WAS NOT NECESSARY. NO OTHER REPORTS OF BREAKAGE HAVE BEEN RECEIVED REGARDING THIS PRODUCT. LOT NUMBER WAS NOT RECORDED BY DOCTOR. SINCE THE SCREW AND WIRE WERE DISCARDED BY THE DOCTOR, NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    VILEX ACCOUNT MANAGER REPORTED THAT A 3.0MM HEADLESS SCREW BENT DURING SURGERY. THE K-WIRE BENT WHILE ADVANCING THE SCREW. THE DOCTOR KEPT TRYING TO ADVANCE THE SCREW, WHICH RESULTED IN THE SCREW BENDING. THE DOCTOR REMOVED THE SCREW AND K-WIRE FROM THE PT. HE TRIED TO REMOVE THE WIRE FROM THE SCREW, SO THAT HE COULD REUSE THE SCREW. THE SCREW HAD BONE FRAGMENT AND METAL SHAVINGS FROM THE WIRE INSIDE IT, SO THE DOCTOR DISCARDED THE SCREW AND WIRE. THE DOCTOR USED ANOTHER SCREW AND WIRE FROM THE VILEX SCREW SET AND THE SURGERY WAS COMPLETED WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VILEX 3.0MM DUAL THREAD "HEADLESS" SCREW 3.0MM DUAL THREAD "HEADLESS" SCREW JDW VILEX IN TENNESSEE, INC F30-20T-11 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1