BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 5673215 · Received May 23, 2016

    Report

    Report Number
    1818910-2016-19851
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    May 17, 2016
    Report Date
    May 17, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. A SEARCH OF THE COMPLAINT DATABASE AGAINST THE REPORTED PRODUCT CODE FOUND ADDITIONAL REPORTS OF END CAP COMPONENT BREAKAGE. (B)(4) WAS PREVIOUSLY INITIATED TO FURTHER INVESTIGATE SIG FEM ADPT TORQUE WRENCH PROTECTOR CAP BREAKAGE AND IDENTIFY CORRECTIVE ACTIONS. (B)(4) HAS BEEN INITIATED TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (B)(4). THE CURRENT REPORTED COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF (B)(4). THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE CURRENT REPORTED BROKEN PROTECTOR CAP WITHOUT THE INSTRUMENT AND PROTECTOR CAP TO EXAMINE. BASED ON THE INABILITY TO CONCLUSIVELY DETERMINE A ROOT CAUSE, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ALTHOUGH THIS INVESTIGATION DID NOT ESTABLISH A NEED FOR CORRECTIVE ACTION, (B)(4) HAS BEEN INITIATED TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (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.

    Description of Event or Problem · 1

    WHEN ASSEMBLING THE TC3 FEMORAL COMPONENT THE BLACK RING BROKE OFF THE TORQUE WRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327996 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2012912

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR