BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SHIM SZ5 6MM

    MDR report key: 6112096 · Received November 18, 2016

    Report

    Report Number
    1818910-2016-31716
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 22, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF TRIAL BREAKAGE. THE ROOT CAUSE IS ATTRIBUTED TO USER TECHNIQUE AND/OR MISUSE. THE DAMAGE SUGGESTS THE TRIAL WAS PRYED OR OTHERWISE INAPPROPRIATELY REMOVED DURING TRIALING. BASED ON THE ROOT CAUSE OF SUSPECTED MISUSE, CORRECTIVE ACTION IS NOT INDICATED. CONTINUE TO MONITOR VIA SEP-(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

    INSTRUMENT FRACTURED INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765862 ATTUNE SHIM SZ5 6MM KNEE INSTRUMENT/TRIAL HWT DEPUY ORTHOPAEDICS, INC. MVMBTM160

    Patients

    Seq Age Sex Outcome Treatment
    1