BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE DISTAL FEMORAL JIG

    MDR report key: 5755621 · Received June 28, 2016

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    Report

    Report Number
    1818910-2016-22335
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    June 27, 2016
    Report Date
    June 27, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DFMEA DVE-107404-FDE FOR THIS INSTRUMENT INDICATES FAILURE OF THE TRIGGER DURING SURGERY OR BROKEN PRIOR TO SURGERY AS A POTENTIAL FAILURE MODES, WITH THE OCCURRENCE SCORE BEING 4 (1 IN 1000 TO 1 IN 10,000). THE DFMEA THEREFORE CORRECTLY CONSIDERS THE EFFECT OF THIS INSTRUMENT BEING BROKEN PRIOR TO THE NEXT SURGERY. THIS FAILURE DOES NOT CHANGE THE OCCURRENCE OF HARM PREDICTED IN THE DFMEA. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. POST MARKET SURVEILLANCE IS PER SEP 419. 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

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    (B)(4). 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.

    Description of Event or Problem · 1

    THE RED BUTTON IS BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410598 ATTUNE DISTAL FEMORAL JIG KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. ABB79390

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR