BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P.F.C.* PRESS-FIT ROD WRENCH

    MDR report key: 5803139 · Received July 19, 2016

    Report

    Report Number
    1818910-2016-23420
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    July 17, 2016
    Report Date
    July 17, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PRESS-FIT ROD WRENCH CONFIRMED THE WRENCH WILL NOT ADJUST. THE EXAMINATION FOUND THE ADJUSTMENT INTERNAL ROD FROZEN/STUCK AND WILL NOT ADVANCE. THE COMPLAINT SAMPLE HAS BEEN SUBJECTED TO HEAVY USAGE. THE ROOT CAUSE IS BEING ATTRIBUTED TO DEVICE WEAR FROM NORMAL USE AND SERVICING. BASED ON THE DETERMINATION OF DEVICE WEAR FROM NORMAL USE AND SERVICING AS THE ROOT CAUSE, NO CORRECTIVE ACTION IS BEING TAKEN AT THIS TIME. CONTINUE TO MONITOR THROUGH SEP-(B)(4). 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

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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.

    Description of Event or Problem · 1

    THE WRENCH CANNOT BE TURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460127 P.F.C.* PRESS-FIT ROD WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. MX0209

    Patients

    Seq Age Sex Outcome Treatment
    1