BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SHIM SZ5 5MM

    MDR report key: 6147627 · Received December 6, 2016

    Report

    Report Number
    1818910-2016-32527
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 28, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES CONFIRMS THE REPORTED EVENT OF TRIAL BREAKAGE. HHE/QRB (QUALITY REVIEW BOARD) 103045639 RECOMMENDED A DEVICE CORRECTION WHICH WAS INITIATED ON JUNE 12, 2015. (B)(4) DETERMINED THE LIKELY ROOT CAUSE TO BE RELATED TO MISUSE, AND REQUIRES MANDATORY SALES TRAINING ON PROPER USE AND APPLICATION OF THE DEVICE BY DEPUY SALES CONSULTANTS. (B)(4) WILL ALSO MONITOR THE MANDATORY FIELD TRAINING. THE NEED FOR FURTHER CORRECTIVE ACTION WAS NOT INDICATED. CONTINUE TO MONITOR PER POST MARKET SURVEILLANCE SEP-419. 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).

    Description of Event or Problem · 1

    THE SURGEON FOUND IT DIFFICULT TO SLIDE THE INSERT TRIAL INTO THE CORRECT POSITION. HE HAD TO USE A MALLET TO GET IT TO FIT PROPERLY. ON 28 NOV 2016 UPON EVALUATION OF THE RETURNED DEVICES, ALL INSTRUMENTS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800219 ATTUNE SHIM SZ5 5MM KNEE INSTRUMENTS HWT DEPUY ORTHOPAEDICS, INC. 1818910 MVMCKZ010

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR