BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIBIAL IMPACTOR

    MDR report key: 5924206 · Received September 2, 2016

    Report

    Report Number
    1818910-2016-26282
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    August 23, 2016
    Report Date
    August 23, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    PMA / PMN Number
    K140881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT THE IMPACTOR IS BROKEN AS REPORTED. 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. THIS DEVICE IS FROM AN ANNEALED BATCH. A FIELD SAFETY NOTICE WAS ISSUED IN (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 A JUSTIFIED 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.

    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.(B)(4).

    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

    THE IMPACTOR HAD A PIECE BREAK OFF WHILE IMPACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575950 ATTUNE FB TIBIAL IMPACTOR KNEE INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 AU3207735

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR