BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VILEX 8.0MM CANNULATED SCREW

    MDR report key: 2190313 · Received July 22, 2011

    Report

    Report Number
    1051526-2011-00002
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    VILEX IN TENNESSEE, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SALES REP FOR COMPANY WAS ABLE TO TAKE PHOTOGRAPHS OF THE SCREW AFTER EXPLANT ALTHOUGH THE FACILITY WOULD NOT RELEASE THE SCREW. RECORDED THE LOT NUMBER. PHYSICIAN SENT X-RAYS. POSSIBLE CONTRIBUTION OF NON-UNION TO POINT OF STRESS. COMPANY RECORDS REVIEWED AND DETERMINED THERE HAD BEEN NO OTHER REPORTED FAILURES SINCE DATE OF MANUFACTURE. INTERNAL TESTS SHOWED DEVICE FROM SAME LOT COULD WITHSTAND GREATER THAN 500 LBS TO BREAK. SENDING A SPECIMEN TO THIRD-PARTY TEST LAB FOR MORE EXTENSIVE ANALYSIS. APPROPRIATE ACTION WILL BE TAKEN AS NECESSARY IF RESULTS INDICATE DEVICE ISSUE. ROOT-CAUSE INDETERMINATE AT THIS TIME.

    Description of Event or Problem · 1

    DR REPORTED AN 8.0MM SCREW BROKE IN A PATIENT. PATIENT PRESENTED AT APPROXIMATELY 4 MONTH POST-OP, AFTER PT SESSION SHE HEARD AND FELT A "POP" IN HER FOOT, AND IMMEDIATE PAIN AND SWELLING IN THE MIDFOOT. TWO WEEKS LATER HAD IT CHECKED, X-RAYS REVEALED SCREW HAD FAILED AT RUNOUT, BUT NOT AT AREA OF DELAYED UNION. DOCTOR REMOVED THE SCREW EXCEPT BROKEN PORTION APPROXIMATELY 1.5MM WHICH REMAINED IN TALUS. REVISED THE TN NON-UNION WITH PLATE AND GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VILEX 8.0MM CANNULATED SCREW 8MM SCREW HWC VILEX IN TENNESSEE, INC. F80-140T-20S 3026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention