BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PATELLA DRILL CLAMP

    MDR report key: 5150267 · Received October 14, 2015

    Report

    Report Number
    1818910-2015-32669
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 24, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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 254501055. (B)(4) 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.

    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. (B)(4). 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

    WHEN CEMENTING THE PATELLA IMPLANT ON, THE PATELLA CLAMP RATCHETED DOWN, BUT WOULDN'T IMMEDIATELY RELEASE TO ALLOW REPOSITIONING. IT TOOK MULTIPLE ATTEMPTS TO RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677474 ATTUNE PATELLA DRILL CLAMP KNEE INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. NW146253

    Patients

    Seq Age Sex Outcome Treatment
    1