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

Model Number	403001-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was completed and components were submitted in place.The physician noticed a large gap in the lateral compartment of the knee.He had concerns that the unit may have maligned the femur, and wanted review of the device.The computer was taken off the field and it read, "navigation unit error, replace with new nav.Unit, return this unit.Stuck key 4.".
Additional Manufacturer Narrative
At this time the product has not been returned for investigation.Once the product is returned orthalign will perform an investigation into the alleged accuracy issue.Orthalign is filing this mdr with an abundance of caution with the understanding of the potential harm that the patient could be subject to if the device produces inaccurate measurements.
Additional Manufacturer Narrative
The navigation log was available for review.The first session showed the nav was paired with rs s/n (b)(6) and the tka procedure was completed.Upon pairing with the returned nav unit, the rs s/n (b)(6) showed a use count of 121.Registration was completed with the femur offset angle and resection angle found to be within tolerance.During tibial registration, the error message "tibia - mount side switching warning" appeared, which means the rs was removed from the intrument and placed on the opposite side.Shortly after the warning, communication was lost with the rs, and the nav was powered down.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 (b)(6) , 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.No fault could be found with the returned navigation unit.The navigation unit powered up and successfully passed horizontal, vertical, and side calibration.The unit also successfully completed multiple simulated maneuvers during testing.The navigation unit was found to function as design.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: ORTHALIGN PLUS NAVIGATION UNIT
• 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: 14042997
• Report Number: 3007521480-2022-00002
• Device Sequence Number: 6300760
• Product Code: OLO
• UDI-Device Identifier: 00810832031369
• UDI-Public: 00810832031369
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 403001-08
• Device Catalogue Number: 403001
• Device Lot Number: 210811020LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown