BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE MOD POST SAW CAP SZ 3-5

    MDR report key: 4852997 · Received June 18, 2015

    Report

    Report Number
    1818910-2015-23890
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 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

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE CAP BUTTON COMPONENT HAS FRACTURED. (B)(4) WAS HELD ON JANUARY 30, 2015 TO EVALUATE PATIENT RISK. BASED UPON THE PROVIDED INFORMATION, THE TEAM DECIDED THERE IS NO ADDITIONAL PATIENT RISK. THE ROOT CAUSE IS DESIGN. A CO ((B)(4)) HAS BEEN INITIATED TO CHANGE THE MATERIAL OF THE MODULAR CAPTURE BUTTON TO STAINLESS STEEL. WITH THIS CHANGE, THE FUNCTIONALITY OF THE BUTTON WILL REMAIN THE SAME, HOWEVER, THE CHANGE IN MATERIAL IS EXPECTED TO IMPROVE THE OVERALL ROBUSTNESS OF THE COMPONENT. THIS CHANGE WILL ALSO AFFECT THE FINISHED GOOD MODULAR CAPTURES (254500044, 254500045, 254500046, 254500047) WITH AN UPDATE TO SWITCH THE BUTTON COMPONENT AT A LATER DATE FOLLOWING LIFECYCLE TESTING OF THE NEW DESIGN. CONTINUE TO MONITOR VIA (B)(4). 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

    PLASTIC PIECE BROKE ON THE SAW CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398735 ATTUNE MOD POST SAW CAP SZ 3-5 KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. PG229046

    Patients

    Seq Age Sex Outcome Treatment
    1