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

Model Number	403001-08
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One nav unit and one reference sensor (rs2) involved in this case were received by orthalign for investigation on 1/31/2023.The behavior reported by the user could not be reproduced by the orthalign engineer.Femoral registration and v/v alignment were completed three times using both returned devices together.The root cause is suspected to be unstable elements during the procedure.After reviewing the navigational log files, the user received several inconsistent hip point errors prior to a successful femur registration.This indicates the femoral jig or the femoral head wasn't stable during registration attempts.This is a possible root cause for the error seen by the user.Since no defect was found with the returned units, the complaint cannot be confirmed.Note: this report is being submitted as an initial report outside of the required 30-day window due to a lapse in access to the fda electronic submissions gateway.After departure of a former employee, new esg accounts were requested starting in september 2022, however, access to the production environment was delayed and still not received in time to submit the initial report within the 30-day window.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.
Event or Problem Description
It was reported that total knee arthroplasty was performed on (b)(6) 2022.Surgeon did the femur registration and installed the guide (v/v was adjusted to zero degrees) in accordance with the procedure.However, after cutting the distal femur bone, she found that it was obviously valgus.Subsequently, she additionally cut the bone to adjust the alignment.The procedure was completed without issue.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer Contact: karyl haskell ; 120 columbia; suite 500; aliso viejo, CA 92656
• MDR Report Key: 16401930
• Report Number: 3007521480-2023-00002
• Device Sequence Number: 5618076
• Product Code: OLO
• UDI-Device Identifier: 00810832031369
• UDI-Public: 00810832031369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 403001-08
• Device Catalogue Number: 403001-08
• Device Lot Number: 220506022LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown