BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PATELLA DRILL CLAMP

    MDR report key: 6154169 · Received December 8, 2016

    Report

    Report Number
    1818910-2016-33063
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 1, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. FOLLOWUP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER, AND THE INFORMATION IS NOT AVAILABLE. 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE PRODUCT DEVELOPMENT TEAM IS AWARE OF THIS COMPLAINT AND HAS A NEW DESIGN TO REPLACE THE BALL PLUNGER WITH A LEAF-SPRING AND INCREASE LATERAL PRESSURIZATION. THIS WILL CREATE A STRONGER CONNECTION BETWEEN THE PATELLA CLAMP AND MODULAR PIECES ALONG WITH A MORE EVEN DISTRIBUTION OF PRESSURE MOVING FORWARD. THE ENHANCED ATTUNE PATELLA DRILL CLAMP WILL BE DISTRIBUTED UNDER PRODUCT CODE 254501055. CO 103089400 WAS APPROVED ON NOVEMBER 25, 2014. NEW DESIGN IS NOW AVAILABLE. 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.

    Description of Event or Problem · 1

    THE SURGEON COMPLAINED THAT THE PATELLA DRILL GUIDE WAS NOT CLICKING ONTO THE PATELLA CLAMP PROPERLY SO THAT IT WAS FALLING OFF WHEN HE WAS TRYING TO CLAMP THE DRILL GUIDE ONTO THE RESECTED PATELLA. THERE WAS NO DELAY IN THE CASE AS THE SURGEON DECIDED TO USE THE TRIAL HANDLE INSTEAD OF THE CLAMP. NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805419 ATTUNE PATELLA DRILL CLAMP KNEE INSTRUMENT/TRIAL HXD DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1