MAUDE Adverse Event Report: ORTHALIGN, INC. LANTERN KNEE; SURGICAL NAVIGATION SYSTEM

Model Number	406000-02
Medical Device Problem Codes	Inadequate User Interface (2958); Delayed Program or Algorithm Execution (4034)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The navigation unit was returned to orthalign for evaluation.The investigation has been completed by an orthalign engineer.The behavior was reproducable and the complaint is confirmed.During the investigation it was discovered that there is a software "bug" that allows the user to skip calibration when the user repeatedly presses and holds on the touch screen at the correct moment in the procedure.The skipping of calibration is readily detectable to the user.For harm to occur, the user must perform the unintended action of skipping calibration and use the device with improper calibration.The absolute accuracy of the navigation unit accelerometers does not directly correlate to the system accuracy,and device inaccuracy is a known risk defined in orthalign's risk documentation.Orthalign will continue to monitor this issue and the software will be updated to correct the "bug".
Event or Problem Description
Customer reported that the navigation unit would not calibrate.Upon receipt of the unit and investigation of the complaint, it was found that the log shows that bt calibration was skipped.

• Brand Name: LANTERN KNEE
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology; irvine, CA 92618
• MDR Report Key: 20034289
• Report Number: 3007521480-2024-00012
• Device Sequence Number: 17785390
• Product Code: OLO
• UDI-Device Identifier: 00810832031567
• UDI-Public: 00810832031567
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K200892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 406000-02
• Device Catalogue Number: 406000-02
• Device Lot Number: 2308124LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown