BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER

    MDR report key: 1062301 · Received June 18, 2008

    Report

    Report Number
    1649384-2008-00318
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    April 11, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW INDICATES THE PART MET SPECIFICATIONS. VISUAL EXAMINATION INDICATES THE TIPS AND SHAFT ARE BENT/TWISTED. AN ENGINEERING EVAL FOUND THE EVENT WAS DUE TO THE HOLLOW SHAFT DESIGN. THE DESIGN CHANGED TO A SOLID SHAFT IN 2006. THE ROOT CAUSE WAS USE ERROR DUE TO USING THE DRIVER FOR SCREW REMOVAL. AN ENHANCEMENT TO THE SURGICAL TECHNIQUE IN 2007, WAS COMPLETED TO INCLUDE ADDITIONAL PRECAUTIONS AGAINST SCREW REMOVAL USE.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT DURING A KIT INSPECTION IT WAS IDENTIFIED THAT THE DRIVER WAS BENT. UPON INVESTIGATION OF THE RETURNED PART TWO MONTHS LATER, IT WAS DETERMINED THE PRODUCT MALFUNCTION WAS FOR PART NUMBER 2155-1 AND NOT 1351-1 AS ORIGINALLY DOCUMENTED. THE MALFUNCTION FOR THE 2155-1 DRIVER, BENT, HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER INCOMPASS HXX ABBOTT SPINE 25YF

    Patients

    Seq Age Sex Outcome Treatment
    1