BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEEALIGN 2

    MDR report key: 8610206 · Received May 14, 2019

    Report

    Report Number
    3007521480-2019-00012
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    April 8, 2019
    Report Date
    June 17, 2021
    Manufacturer
    ORTHALIGN INC.
    Product Code
    OLO
    UDI-DI
    00858704006015
    PMA / PMN Number
    K163379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRESENCE OF MOISTURE IS SUSPECTED TO BE IMPACTING THE INTERNAL SENSOR RESULTING IN THE HIGH DEGREE REPORTED ON THE NAVIGATION UNIT AS DESCRIBED WITHIN THE COMPLAINT. THE UNIT WAS LEAK TESTED AND FOUND THAT THE HOUSING WAS COMPROMISED WHICH IS THE ROOT CAUSE OF THE ABUNDANCE OF MOISTURE PRESENT WITHIN THE DEVICE. 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. MOLD REDESIGN IMPROVEMENTS FOR THE REFERENCE SENSOR 2 HAVE BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    AN ORTHALIGN DISTRIBUTOR REPORTED THAT THE REFERENCE SENSOR USED DURING A TOTAL KNEE ARTHROPLASTY HAD MOISTURE INSIDE AND THAT IS THE BELIEVED CAUSE OF THE REPORTABLE COMPLAINT REGARDING THE SYSTEM ACCURACY. THE SURGEON WAS LOOKED FOR A FLEXION DEGREE OF 2 AND THE NAVIGATION UNIT READ 18 DEGREES FLEXION AFTER KNEE MOVEMENTS. THIS IS OUTSIDE OF THE FDA CLEARED CLAIM OF +/- 3 DEGREES. ONCE THE DEVICE IS RETURNED AND INVESTIGATED A FOLLOW UP REPORT WILL BE FILED. ORTHALIGN IS FILING THIS INITIAL MDR WITH EXTREME CAUTION WHILE CONSIDERING THE RISK TO THE PATIENT WITH A DEVICE BEING INACCURATE AND THE POTENTIAL HARM THAT COULD CAUSE.

    Description of Event or Problem · 1

    SENSOR HAS MOISTURE INSIDE AND ORTHALIGN PLUS UNIT READ 18* FLEXION AFTER KNEE MOVEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402389 KNEEALIGN 2 REFERENCE SENSOR OLO ORTHALIGN INC. 133632 NA 00858704006015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R