BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED POLY SCREWDRIVER II-MOD

    MDR report key: 1190742 · Received October 6, 2008

    Report

    Report Number
    1649384-2008-00525
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2009
    Report Date
    October 6, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW INDICATE THE PART MET SPECIFICATION. THE VISUAL EXAMINATION AND FUNCTIONAL EVALUATION OF THE RETURNED PART DID NOT REPLICATE THE REPORTED EVENT. THE INVESTIGATION DETERMINED THE MOST LIKELY CAUSE OF THE EVENT DURING SURGERY IS USE ERROR.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT DURING SURGERY IN 2008, THE CANNULATED POLY SCREWDRIVER DID NOT ALIGN WITH THE SCREWS. THE SURGEON WAS ABLE TO COMPLETE THE CASE AS INDICATED AND THERE WAS MINIMAL SURGICAL DELAY. THERE WAS NO HARM TO THE PT. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED POLY SCREWDRIVER II-MOD PATHFINDER HXX ABBOTT SPINE 20XF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK