BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PATELLA DRILL CLAMP

    MDR report key: 6174713 · Received December 15, 2016

    Report

    Report Number
    1818910-2016-33452
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 12, 2016
    Report Date
    December 12, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED PATELLA DRILL CLAMP WAS UNABLE TO CONFIRM THE REPORTED EVENT AS THE CLAMP FUNCTIONED AS INTENDED. A COMPLAINT DATABASE SEARCH ON THE PROVIDED PRODUCT CODE IDENTIFIED SIMILAR REPORTS. THE PRODUCT DEVELOPMENT TEAM IS AWARE OF THIS COMPLAINT AND HAS A NEW DESIGN TO MITIGATE THE REPORTED FAILURE. PREVIOUS INVESTIGATIONS AND EVALUATIONS FOUND THAT THE FAILURE MAY HAVE OCCURRED WHILE THE CLAMP WAS BEING SQUEEZED UNDER VERY HIGH LOADS AND THE BEARINGS INSIDE OF THE CYLINDER WERE EXTRUDING SLIGHTLY, CAUSING THE MECHANISM TO STICK. THE ENHANCED ATTUNE PATELLA DRILL CLAMP WILL BE DISTRIBUTED UNDER PRODUCT CODE (B)(4). (B)(4) WAS APPROVED ON (B)(6) 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.

    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

    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

    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.

    Description of Event or Problem · 1

    THE CLAMP IS GETTING STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830114 ATTUNE PATELLA DRILL CLAMP KNEE INSTRUMENT/TRIAL HXD DEPUY ORTHOPAEDICS, INC. NW151231

    Patients

    Seq Age Sex Outcome Treatment
    1