BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET RATCHET SCDR HDL

    MDR report key: 3994315 · Received August 8, 2014

    Report

    Report Number
    1818910-2014-25279
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH VISUAL EXAMINATION FOUND THE CAP RETENTION PULLED APART FROM THE BLACK HANDLE A FUNCTIONAL TEST CONDUCTED WITH A MATING SCREWDRIVER FOUND THE RATCHET FUNCTIONED AS INTENDED. ALTHOUGH DESIGN IMPROVEMENTS TO IMPROVE THE CAP RETENTION AND THE RATCHET ENGAGEMENT WERE ESTABLISHED THROUGH ECO 343292 IN JANUARY 2011, THE INSTRUMENT IS EXTREMELY OLD AND WORN. THE CAUSE IS ATTRIBUTED TO HEAVY USAGE/WEAR OUT. THE DATE CODE PG0804 INDICATES THE PRODUCT WAS MANUFACTURED IN AUGUST OF 2004 AND IS OVER 10 YEARS OLD. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY..

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    TIPS IS BROKEN OFF THE DRILL GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467106 QUICKSET RATCHET SCDR HDL HIP INSTRUMENT/TRIAL LXH 1818910 DEPUY ORTHOPAEDICS, INC. PS0804

    Patients

    Seq Age Sex Outcome Treatment
    1