BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SHIM SZ3 5MM

    MDR report key: 6078460 · Received November 4, 2016

    Report

    Report Number
    1818910-2016-30547
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 25, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF TRIAL BREAKAGE. ALL PIECES WERE RETURNED FOR EVALUATION. 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-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.

    Description of Event or Problem · 1

    THE STERILE PROCESSING DEPARTMENT NOTIFIED THE SALES REP THAT THE SHIM TRIAL HAD CRACKED IN HALF WHEN IT WAS REMOVED FROM THE INSERT TRIAL. ON 25 OCTOBER 2016 UPON EVALUATION OF THE RETURNED DEVICE, SHIM IS BROKEN IN TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730110 ATTUNE SHIM SZ3 5MM KNEE INSTRUMENTS HWT DEPUY ORTHOPAEDICS, INC. 1818910 MVMBKX640

    Patients

    Seq Age Sex Outcome Treatment
    1