BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIBIAL IMPACTOR

    MDR report key: 5401301 · Received February 1, 2016

    Report

    Report Number
    1818910-2016-12356
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Date of Event
    January 28, 2016
    Report Date
    January 29, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES INTRAOPERATIVELY THE IMPACTORS BROKE. THE INVESTIGATION CONFIRMED THAT THE IMPACTORS HAD BROKEN AS REPORTED. EXPERT OPINION INDICATES THAT THE FAILURES ARE ASSOCIATED WITH ENVIRONMENTAL STRESS CRACKING (ESC). THE ATTUNE IMPACTORS HAVE 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 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 STILL 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 UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE 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. (B)(4).

    Description of Event or Problem · 1

    INTRAOPERATIVELY THE IMPACTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59590 ATTUNE FB TIBIAL IMPACTOR KNEE INSTRUMENT/TRIAL HWA DEPUY ORTHOPAEDICS, INC. AU3784954

    Patients

    Seq Age Sex Outcome Treatment
    1