BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REV FEM/TIB/SLEEVE CLAMP

    MDR report key: 6056801 · Received October 26, 2016

    Report

    Report Number
    1818910-2016-30193
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). 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

    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 ACESS DEPUY TO ADDRESS ISSUES IN THE FIELD RELATED TO USE OF THE 217863134 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CLAMP GETS STUCK WHEN PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707847 REV FEM/TIB/SLEEVE CLAMP KNEE INSTRUMENT/TRIAL HXD DEPUY ORTHOPAEDICS, INC. 1818910 H0804

    Patients

    Seq Age Sex Outcome Treatment
    1