BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREWDRIVER

    MDR report key: 2803208 · Received July 1, 2009

    Report

    Report Number
    9615741-2009-00079
    Event Type
    Malfunction
    Date Received
    July 1, 2009
    Date of Event
    December 17, 2008
    Report Date
    July 1, 2009
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. A REVIEW OF THE MFG RECORD FOUND NO ANOMALIES DURING THE MFG PERIOD OF THE PRODUCT. A REVIEW OF THE COMPLAINT SYSTEM SHOWED THAT THIS IS THE SEVENTH REPORTED INCIDENT FOR A PEG BREAKAGE OF HALLU-FIX SCREWDRIVERS IN THE PAST TWO YEARS. (B)(4). PRIOR TO RELEASE, INSPECTION OF LASER MARKING AND DOCUMENTATION IS DONE FOR ALL HALLU-FIX SCREWDRIVERS; A TWENTY PERCENT SAMPLE IS TESTED FOR COMPLIANCE TO FUNCTIONAL SPECIFICATIONS. GIVEN THE DESCRIPTION OF THE EVENT AND THE LACK OF RETURNED PRODUCT, THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. ACCORDING TO THE DEVICE MFG RECORD, THE DEVICE IS IN COMPLIANCE WITH OUR SPECIFICATIONS. NO CORRECTIVE ACTION HAS BEEN TAKEN AT THIS TIME. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE HALLU-FIX SCREWDRIVER BROKE OFF DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREWDRIVER LOWER EXTREMITY FIXATION SYSTEM HXX NEWDEAL S.A. E1KX

    Patients

    Seq Age Sex Outcome Treatment
    1