BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL INTRODUCER

    MDR report key: 5692294 · Received June 1, 2016

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    Report

    Report Number
    1818910-2016-20424
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Date of Event
    May 25, 2016
    Report Date
    May 25, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS TRANSFERRED TO BIOENGINEERING FOR REVIEW, A REPORT WAS RECEIVED STATING; BOTH FAILURE MODES; PATIENT HARM AND DELAY TO SURGERY HAVE BEEN ADEQUATELY COVERED IN THE RISK ASSESSMENT (DVA-105445-FDE) OF THE DEVICE AND NO FURTHER UPDATES ARE REQUIRED. THE COMPLAINT MENTIONS THAT THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM HAS BEEN REPORTED. THE OPERATION OF THE RETURNED DEVICE WAS SMOOTH BY ROTATING THE CENTRAL THUMB WHEEL WITH NO INDICATION OF JAMMING. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND ENTERED INTO THE COMPLAINTS SYSTEM AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. 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

    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 SIDE KNOB ON THE FEMORAL INTRODUCER BROKE OFF THE INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346665 ATTUNE FEMORAL INTRODUCER KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. ABB47842

    Patients

    Seq Age Sex Outcome Treatment
    1