BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON RONGEUR (40 DEG FWD), 4MM

    MDR report key: 1193192 · Received October 7, 2008

    Report

    Report Number
    1649384-2008-00501
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DID NOT OCCUR IN SURGERY. RESULTS OF DEVICE HISTORY RECORD REVIEW INDICATED THAT PRODUCT MET SPECIFICATIONS. VISUAL EXAMINATION FOUND MISSING PIVOT SCREW/PIN. THE ENGINEERING INVESTIGATION DETERMINED THE ROOT CAUSE WAS NO MECHANICAL LOCK TO SECURE THE PIVOT SCREW/PIN. THE CORRECTIVE ACTION TAKEN WAS TO ADD A MECHANICAL LOCK TO THE SPECIFICATION IN 2008.

    Description of Event or Problem · 1

    IN 2008, THE OFFICE MANAGER REPORTED THAT DURING A KIT INSPECTION, IT WAS IDENTIFIED THAT THE SCREW WAS MISSING AND THE INSTRUMENT WAS NON-FUNCTIONAL. THIS MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON RONGEUR (40 DEG FWD), 4MM HARMONY HTX ABBOTT SPINE 21SZ

    Patients

    Seq Age Sex Outcome Treatment
    1