BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEEALIGN 2

    MDR report key: 11681557 · Received April 16, 2021

    Report

    Report Number
    3007521480-2021-00005
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 12, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006008
    PMA / PMN Number
    K103829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED NAVIGATION UNIT WAS TESTED WITH AND IN-HOUSE REFERENCE SENSOR BY PERFORMING A BACK-TABLE CALIBRATION, AND THEN SIMULATING FEMORAL AND TIBIAL REGISTRATIONS SEVERAL TIMES. ALL TESTED ATTEMPTS FOUND NO ISSUES WITH THE NAVIGATION UNIT. ALL DEVICES, BOTH RETURNED IN THE COMPLAINT, AND IN-HOUSE TO ORTHALIGN, WERE ABLE TO PAIR AND MECHANICALLY INTERFACE TO THE RETURNED NAVIGATION UNIT WITHOUT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION IF ALERT LIMITS ARE EXCEEDED.

    Additional Manufacturer Narrative · 1

    AN ORTHALIGN DISTRIBUTOR REPORTED THAT DURING A TKA PROCEDURE A CUT WAS PERFORMED AND THE CUT WAS MUCH LARGER THAN THE SURGEON INTENDED. THIS CAUSED PROLONGED SURGICAL TIME, BUT AT THIS TIME THERE IS NO KNOWN INJURY TO THE PATIENT. AN INVESTIGATION WILL BE PERFORMED ONCE THE UNIT IS RETURNED FROM ORTHALIGN INC.'S DISTRIBUTOR IN SINGAPORE. WITH AN ABUNDANCE OF CAUTION THIS REPORT IS BEING FILED WITH THE UNDERSTANDING OF THE POTENTIAL PATIENT HARM THAT COULD BE CAUSED TO THE PATIENT BY AN INACCURATE DEVICE MEASUREMENT AND PROLONGED SURGICAL TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL CALIBRATION WAS DONE AND PASSED. KNEEALIGN POD HAS REGISTERED FEMUR OFFSET AND CENTRE OF HIP ROTATION PERFORMED BY SURGEON. SURGEON ADJUSTED FINAL ANGLE AS VARUS 1 DEGREE FOR FEMURCUTTING BLOCK TO SIT HOWEVER UPON REMOVING THE KNEEALIGN POD AND SENSOR, AN OBVIOUS VALGUS CUT WAS SHOWN WHEN THE SURGEON DOUBLE CHECK WITH A RESECTION GUIDE PRIOR SAWING THE FEMUR. SURGEON ABORT THE USAGE OF KNEEALIGN IN ASSISTING FOR FEMUR CUTS AND PROCEED ON USING CONVENTIONAL JIG INSTEAD. SURGEON THEN ATTEMPT TO USE KNEE-ALIGN AGAIN FOR TIBIAL CUTS, SAME OUTCOME AS ABOVE MENTIONED. SURGEON DECIDED TO PROCEED WITH CONVENTIONAL SAWING WITHOUT THE AID OF NAVIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578403 KNEEALIGN 2 NAVIGATION UNIT OLO ORTHALIGN, INC. 133631 00858704006008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention