BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHALIGN PLUS SYSTEM

    MDR report key: 12010610 · Received June 16, 2021

    Report

    Report Number
    3007521480-2021-00007
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 11, 2021
    Report Date
    November 12, 2021
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00851977007901
    PMA / PMN Number
    K171780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6 CODES INVESTIGATION FINDINGS: 3213, INVESTIGATION CONCLUSIONS: 44. DURING INVESTIGATION A REVIEW OF THE EVENT LOG FOUND THAT THERE WERE SEVERAL ATTEMPTS TO COMPLETE THE FEMORAL MANEUVER WHILE PAIRED WITH THE REFERENCE SENSOR 2 SN (B)(6) BUT THE PROCEDURE WAS NOT COMPLETED. USING AN ORTHALIGN MECHANICALLY FABRICATED FEMORAL PLATFORM, THE RETURNED NAVIGATION UNIT AND REFERENCE SENSOR 2 WERE ATTACHED TO THE MICROBLOCK AND THE FEMORAL MANEUVER WAS PERFORMED. AFTER THE SENSORS WERE ATTACHED TO THE MICROBLOCK, THE POSITION NECESSARY TO ALIGN THE NAVIGATION TARGET ON THE NAVIGATION UNIT SCREEN RESULTED IN AN ANGLE THAT WAS ABNORMALLY HIGH. WHEN THE LEG WAS ALIGNED IN A NORMAL POSITION, THE TARGET ON THE NAVIGATION UNIT SCREEN WAS NOT REACHED. THE RETURNED NAVIGATION UNIT PASSED TESTS WITH THE IN-HOUSE REFERENCE SENSOR 2 UNIT TO CONFIRM ACCURACY, BUT FAILED THE FEMORAL MANEUVER WHEN PAIRED WITH THE RETURNED REFERENCE SENSOR 2 SN (B)(6). A FUNCTIONAL TEST WAS PERFORMED ON THE RETURNED NAVIGATION UNIT AND AN IN-HOUSE REFERENCE SENSOR. THE NAVIGATION UNIT SUCCESSFULLY PERFORMED SIMULATED PROCEDURES WHEN PAIRED TO THE IN-HOUSE REFERENCE SENSOR. THE NAVIGATION UNIT WAS FOUND TO FUNCTION AS DESIGNED. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION WHEN/IF ALERT LIMITS ARE EXCEEDED.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE INCORRECT REFERENCE SENSOR WAS RETURNED. THE HISTORY OF THE NAV. UNIT WAS REVIEWED VIA THE DOWNLOADED LOGS FROM ITS NON-VOLATILE MEMORY. THE EVENT LOG SHOWED THERE WERE MANY "HIP SEARCH FAILED: SLIP DETECTED" MESSAGES. 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 WHEN/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 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 (B)(4). 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 TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEE ALIGN. WHEN SURGEON CHECKED THE PATIENT'S FEMUR BONE AND DISTAL OSTEOTOMY SURFACE WITH IMAGE DURING SURGERY, HE FOUND THAT THE VALGUS ANGLE WAS TOO MUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907582 ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT OLO ORTHALIGN, INC. 403001-05 00851977007901

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown