BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE BAL SIZER DISTRACTOR

    MDR report key: 6125676 · Received November 23, 2016

    Report

    Report Number
    1818910-2016-31972
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES THE BALANCE SIZER WOULD NOT PROPERLY TURN IN EITHER DIRECTION. THE STYLUS WILL NOT SIDE OVER THE BALANCED SIZER. THE DEVICES WERE REVIEWED BY BIOENGINEERING AND A REPORT WAS RECEIVED STATING THE PRONGS HAVE BEEN MEASURED WITH VERNIER CALIPERS TO DETERMINE THE RELATIVE DEFORMATION OF THE DEVICE. IT¿S FOUND THAT THE PRONGS HAVE BEEN BENT INWARD, AND THE LOCKING NUT IS MISSING FROM THE DEVICE. ROOT CAUSE: USE ERROR. THE COMPLAINT SHALL BE CLOSED WITH TO USER ERROR; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. POST MARKET SURVEILLANCE IS PER SEP 419. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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. UDI: (B)(4).

    Description of Event or Problem · 1

    THE BALANCE SIZER WOULD NOT PROPERLY TURN IN EITHER DIRECTION. THE STYLUS WILL NOT SIDE OVER THE BALANCED SIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775274 ATTUNE BAL SIZER DISTRACTOR KNEE INSTRUMENTS JWH DEPUY ORTHOPAEDICS, INC. 1818910 ABA91778

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR