BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIBIAL IMPACTOR

    MDR report key: 5933391 · Received September 7, 2016

    Report

    Report Number
    1818910-2016-26665
    Event Type
    Malfunction
    Date Received
    September 7, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 29, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT AS NO DEVICE WAS RETURNED. EXPERT OPINION INDICATES THAT THE FAILURES ARE ASSOCIATED WITH ENVIRONMENTAL STRESS CRACKING (ESC). THE ATTUNE FB TIBIAL IMPACTOR HAS BEEN ANNEALED TO REDUCE RESIDUAL STRESSES. LAB TESTS INDICATE SIGNIFICANT REDUCTION IN RESIDUAL STRESSES OF ANNEALED SAMPLES IN COMPARISON TO UN-ANNEALED SAMPLES HOWEVER A COMPLETE REDUCTION IN STRESSES IS NOT ACHIEVABLE. A FIELD SAFETY NOTICE WAS ISSUED(B)(6) 2014 STATING TO REDUCE THE POSSIBILITY OF LEAVING FRAGMENTS IN PATIENTS, THE COMPANY SUGGESTS ADHERING TO THE INSTRUCTIONS FOR USE (IFU), WHICH INCLUDE INSPECTING THE IMPACTOR¿S TO ENSURE THAT NO INSTRUMENTS OR PIECES OF INSTRUMENTS ARE LEFT IN THE SURGICAL SITE PRIOR TO CLOSURE. IT SHOULD BE NOTED THAT CAPA-003835 HAS BEEN INITIATED AND CAN BE REFERENCED FOR FURTHER DETAILS. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE IMPACTOR BROKE IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584700 ATTUNE FB TIBIAL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1