BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA FINAL DRIVER (PLE)

    MDR report key: 2066109 · Received March 25, 2011

    Report

    Report Number
    1649384-2011-00024
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Removal / Correction Number
    1649384-02/28/2011-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PART MET SPECIFICATION. VISUAL EVALUATION OF THE FINAL DRIVER REVEALED ROUNDED CORNERS OF THE HEX TIP EDGES AND MATERIAL DEFORMATION WITH PREVIOUS DAMAGE FROM NOT FULLY SEATING, LEADING TO FINAL FAILURE OF THE DRIVERS. IT IS NOT KNOWN WHEN THE INITIAL DAMAGE OCCURRED. TEST RESULTS HAVE SHOWN SIMILAR ROUNDING OF THE HEX FEATURE DUE TO INCOMPLETE ENGAGEMENT AND NON AXIAL ALIGNMENT OF THE INSTRUMENT WITH THE CLOSURE TOP DURING FINAL TIGHTENING. A FIELD ACTION, 1649384-02/28/2011-001-C, TO INFORM USERS TO ENSURE COMPLETE INSTRUMENT ENGAGEMENT WITH THE CLOSURE TOP AND MAINTAIN ON AXIS USE DURING FINAL TIGHTENING HAS BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, TWO DRIVERS STRIPPED WHILE FINAL TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA FINAL DRIVER (PLE) FINAL DRIVER NKB ZIMMER SPINE 3384-2 60LL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR