BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 5955675 · Received September 16, 2016

    Report

    Report Number
    1818910-2016-27262
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. A SEARCH OF THE COMPLAINT DATABASE AGAINST PRODUCT CODE 961673 FOUND ADDITIONAL REPORTS OF END CAP COMPONENT BREAKAGE. CAPA (B)(4) WAS PREVIOUSLY INITIATED TO FURTHER INVESTIGATE SIG FEM ADPT TORQUE WRENCH PROTECTOR CAP BREAKAGE AND IDENTIFY CORRECTIVE ACTIONS. CO (B)(4) HAS BEEN INITIATED TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (B)(4). THE CURRENT REPORTED COMPLAINT SAMPLE HAS AN UNKNOWN MANUFACTURE DATE. 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, CO (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.

    Description of Event or Problem · 1

    THE FEMORAL ADAPTER TORQUE WRENCH IS MISSING THE BLACK RING. IT WAS REMOVED FROM THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609374 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENTS HXC DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1