BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REV FEM/TIB/SLEEVE CLAMP

    MDR report key: 6033200 · Received October 17, 2016

    Report

    Report Number
    1818910-2016-29403
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    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

    ADDITIONAL NARRATIVE: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE WRENCH WAS NOT FUNCTIONING PROPERLY. THE HANDLE INTERMITTENTLY STICKS/JAMS AS REPORTED. PREVIOUS INVESTIGATION INTO THIS FAILURE FOUND ROOT CAUSE IS ATTRIBUTED TO EXCESSIVE TORQUE APPLIED TO THE HANDLE WHILE TIGHTENING STEMS. IN OCTOBER OF 2007, DEPUY KNEE MARKETING POSTED AN ARTICLE ON ACCESS DEPUY TO ADDRESS ISSUES IN THE FIELD RELATED TO USE OF THE (B)(4) REV FEM/TIB/SLEEVE CLAMP. THE ARTICLE STATES THAT EXCESSIVE FORCES PLACED ON THE CLAMP DURING EFFORTS TO SECURE THE ADAPTER CAN CONTRIBUTE TO THE INSTRUMENT DAMAGE AND BECOMING NON-FUNCTIONAL. IN ADDITION, THE ARTICLE SUGGESTS PROPER LUBRICATION MAY CONTRIBUTE TO KEEPING THE CLAMP FUNCTIONING PROPERLY. BASED ON THE INVESTIGATION DETERMINATION OF EXCESSIVE TORQUING AS THE PRIMARY ROOT CAUSE AND WEAR OUT AS A LIKELY CONTRIBUTING FACTOR, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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. 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 FEM/TIB WRENCH WAS STICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685432 REV FEM/TIB/SLEEVE CLAMP KNEE INSTRUMENTS HXD DEPUY ORTHOPAEDICS, INC. 1818910 H0907

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR