BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV TIBIAL ALIGMENT HANDLE-TRIATHLON

    MDR report key: 6644940 · Received June 15, 2017

    Report

    Report Number
    0002249697-2017-01881
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    May 10, 2017
    Report Date
    October 31, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EVENT TYPE ASSOCIATED WITH THIS DEVICE WAS FURTHER REVIEWED BY A HEALTH CARE PROFESSIONAL ON 10/20/2017. THE CLINICIANS' ASSESSMENT OF THE EVENT CONFIRMED THAT, "INABILITY TO USE THE TRACKER WOULD RESULT IN CONVERSION TO NON-NAVIGATED SURGERY. SINCE OUTCOMES ARE SIMILAR FOR NAVIGATED AND NON-NAVIGATED SURGERY; THERE IS NO HARM TO THE PATIENT¿ THEREFORE THIS EVENT IS BEING DEEMED NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A TKA, A SURGEON COULD NOT CONNECT TRACKERS (6003-024-000 & 6003-034-000) TO THE REPORTED ALIGNMENT HANDLE. BECAUSE, THE CONNECT PART OF HANDLE WAS TOO THICK. IT WAS REPORTED THAT THEY WERE ABLE TO ATTACH HANDLE PROPERLY WITH A DIFFERENT PIN OR MECHANICAL ADAPTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A TKA, A SURGEON COULD NOT CONNECT TRACKERS ((B)(4)) TO THE REPORTED ALIGNMENT HANDLE. BECAUSE, THE CONNECT PART OF HANDLE WAS TOO THICK. IT WAS REPORTED THAT THEY WERE ABLE TO ATTACH HANDLE PROPERLY WITH A DIFFERENT PIN OR MECHANICAL ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423489 NAV TIBIAL ALIGMENT HANDLE-TRIATHLON ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH 6764901H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other