BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SCREWDRIVER - MODULAR TI

    MDR report key: 1052274 · Received May 23, 2008

    Report

    Report Number
    1649384-2008-00277
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DID NOT OCCUR IN SURGERY. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW INDICATE THE PART MET SPECIFICATION. VISUAL INSPECTION FOUND THE PRONGS OF THE DRIVER TO BE BROKEN OFF IN THE DIRECTION OF LOOSENING. AN ENGINEERING EVALUATION DETERMINED THAT DAMAGE PRONGS ARE THE RESULT OF ATTEMPTING TO REMOVE HARDWARE WITH THE DRIVER. THE SURGICAL TECHNIQUE WAS UPDATE IN 2007 WITH ENHANCED PRECAUTIONS.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING A KIT INSPECTION IT WAS IDENTIFIED THAT THE PRONGS OF THE DRIVER WERE DAMAGED. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN SCREWDRIVER - MODULAR TI INCOMPASS HXX ABBOTT SPINE 25YE

    Patients

    Seq Age Sex Outcome Treatment
    1