BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEEALIGN 2

    MDR report key: 14286500 · Received May 5, 2022

    Report

    Report Number
    3007521480-2022-00003
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 6, 2022
    Report Date
    September 27, 2022
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006008
    PMA / PMN Number
    K103829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. ONCE THE PRODUCT IS RETURNED FROM ORTHALIGN INC.'S DISTRIBUTOR IN SINGAPORE, AN INVESTIGATION INTO THE ALLEGED ACCURACY ISSUE WILL BE PERFORMED . 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.

    Additional Manufacturer Narrative · 0

    THE NAVIGATION LOG WAS AVAILABLE FOR REVIEW. THE FIRST TWO SESSIONS SHOWED THE KA2 WAS PAIRED TO RS S/N 8038 AND THE TKA PROCEDURE WAS COMPLETED IN EACH SESSION. UPON PAIRING WITH THE RETURNED KA2 UNIT, THE RS S/N 8038 SHOWED A USE COUNT OF 100 IN THE FIRST SESSION AND 101 IN THE SECOND SESSION. IN BOTH SESSIONS, REGISTRATION WAS COMPLETED WITH THE FEMUR OFFSET ANGLE AND RESECTION ANGLE FOUND TO BE WITHIN TOLERANCE. A POWER TEST OF THE KA2 UNIT WAS INITIATED BY PRESSING THE CENTER BUTTON. THE SCREEN REMAINED BLACK, AND THE UNIT DID NOT POWER ON. THE ANGLE OF FLEXION IS MEASURED BY THE REFERENCE SENSOR, AND THIS DATA IS COMMUNICATED TO THE NAV UNIT. IT IS SUSPECTED THAT THE REFERENCE SENSOR S/N 0667, WHICH WAS FOUND IN THE NAVIGATIONAL LOG, MAY HAVE EXPERIENCED AGE-RELATED GYRO BIAS DUE TO ITS HIGH USE COUNT. THE RS WAS NOT RETURNED FOR INVESTIGATION. THE KA2 WAS OPENED TO INSPECT THE BATTERIES. IT WAS OBSERVED THAT ONE BATTERY HAD LEAKED INSIDE THE UNIT, AS EVIDENCED BY DRIED BATTERY ACID ON THE BATTERY AND ITS CORRESPONDING BATTERY CLIP. IT CANNOT BE DETERMINED IF THIS BATTERY LEAKED BEFORE OR AFTER THE COMPLAINT EVENT. WITH THE BATTERIES AND THE PCB NO LONGER IN ACCEPTABLE CONDITION, A PROCEDURE COULD NOT BE PERFORMED ON THE KA2 AND FURTHER INVESTIGATION COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE POD WAS NOT CORRESPONDENCE WITH THE SENSOR OF THE KNEEALIGN. THE READING ON THE SCREEN WAS SHOWN AS 13 DEGREE FLEXION, WITH SURGEON CHECKED ON THE RESECTION GUIDE AND IT'S NOT. THE ISSUE WAS COMPLETED WITH OPEN A NEW KNEEALIGN2 CONSUMABLE AND CHANGE OF THE KNEEALIGN SENSOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462855 KNEEALIGN 2 NAVIGATION UNIT OLO ORTHALIGN, INC. 133631 211109046LS 00858704006008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown