BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PATELLA DRILL CLAMP

    MDR report key: 6159489 · Received December 9, 2016

    Report

    Report Number
    1818910-2016-32959
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HXD
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED PATELLA DRILL CLAMPS DETERMINED THAT THE BALL PLUNGER WAS FUNCTIONAL, HOWEVER THE CONNECTION WAS LOOSE. 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. (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.

    Description of Event or Problem · 1

    THE ATTUNE PATELLA MODULAR CLAMP FAILED TO HOLD ONTO THE METAL PATELLA DRILL GUIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808612 ATTUNE PATELLA DRILL CLAMP KNEE INSTRUMENTS HXD DEPUY ORTHOPAEDICS, INC. 1818910 NW144542

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR