BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE S

    MDR report key: 1021524 · Received March 26, 2008

    Report

    Report Number
    2648920-2008-00016
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 4, 2008
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: BOTH RELATED LOTS WERE MANUFACTURED APPROXIMATELY 15 YEARS APART AND IT IS HIGHLY UNLIKELY THAT THE SAMPLE DEVICE WAS ORIGINALLY PACKAGED IN THIS CONDITION GIVEN THE MANUFACTURING TIME SPAN. THE MANUFACTURING RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE DEVICE WAS RETURNED WITH THE SHRINK WRAP MATERIAL NOT INTACT AND TAPE WAS OBSERVED OVER THE TAMPER PROOF LABELS. DISTRIBUTION RECORDS SHOW BOTH THE SAMPLE DEVICE LOT AND THE PACKAGING MATERIAL LOT WERE RECEIVED BY THE RELATED DISTRIBUTOR AND IT IS POSSIBLE THAT THIS SITUATION MAY HAVE OCCURRED AFTER THE DEVICE WAS DISTRIBUTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE NURSE PULLED THE BOX OFF OF THE SHELF TO OPEN IN THE FIELD IN SURGERY. WHEN SHE OPENED THE BOX, INSIDE WAS AN IMPLANT MARKED "SAMPLE". THERE WAS NO PACKAGING AROUND THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE S FEMORAL FIXATION KTT ZIMMER MANUFACTURING B.V. NA 60619098

    Patients

    Seq Age Sex Outcome Treatment
    1