BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW DRILL

    MDR report key: 1963618 · Received January 11, 2011

    Report

    Report Number
    1818910-2011-00847
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS RECEIVED BY THE DEPUY COMPLAINT HANDLING UNIT ON JANUARY 10, 2011. BASED ON THE PRELIMINARY INVESTIGATION, ON JANUARY 12, 2011, DEPUY DIRECTED ALL DISTRIBUTORS TO CANCEL ALL PENDING SURGERIES AND DISCONTINUE USE OF THE SETS UNTIL OUR INVESTIGATION IS COMPLETED. ON JANUARY 14, 2011, DEPUY DIRECTED ALL DISTRIBUTORS TO RETURN THE INSTRUMENTS TO DEPUY FOR INSPECTION AS PART OF THE INVESTIGATION. WE CONSIDER THE ACTION TAKEN ON JANUARY 12, 2011 TO BE A REMEDIAL ACTION REQUIRING A 5 DAY REPORT UNDER 21 CFR PART 803.53(A).

    Description of Event or Problem · 1

    THE CANNULA FOR THE DRILL IS NOT SAME SIZE AT BOTH ENDS. DRILL IS GRABBING GUIDEWIRE AND ADVANCING NOT ALLOWING TO FINISH REAMING, RESULTING IN THE POSSIBILITY OF THE GUIDEWIRE PROGRESSING THROUGH AND PENETRATING THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW DRILL 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA E2FGS4

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR