BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL INTRODUCER

    MDR report key: 5735106 · Received June 20, 2016

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    Report

    Report Number
    1818910-2016-21707
    Event Type
    Malfunction
    Date Received
    June 20, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 14, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES THE SMALL RED KNOB ON THE FEMORAL IMPACTOR BROKE OFF. THE INVESTIGATION CONFIRMED THE FAILURE MODE REPORTED AS THE LOCK KNOB HAD BROKEN. 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.

    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.

    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. 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 SMALL RED KNOB ON THE FEMORAL IMPACTOR BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391014 ATTUNE FEMORAL INTRODUCER KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. ABC25925

    Patients

    Seq Age Sex Outcome Treatment
    1