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

Model Number	403001-08
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time the product has not been returned for investigation.Once the product is returned 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.
Event or Problem Description
It was reported that the femoral and tibia cuts were made using the orhalign computer.After completion of cuts the surgeon thought the tibia cut looked like it had an anterior slope of around 10 degrees (the jig was dialed to zero degrees v/v and zero degrees posterior slope).He also thought the femoral cut was in too much flexion + in varus (jig was set to zero gegrees v/v and 3 degrees fem flexion).Tibia had to be recut with extramedullary guide.
Additional Manufacturer Narrative
A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.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.The navigation log was available for review, and it showed nine very brief sessions before session 10, where the failure event was found.Sessions 1, 2, 3, and 6 were interrupted by battery errors.Session 5 had a watchdog error.Sessions 4, 7, 8, and 9 were brief sessions where the nav was powered on successfully, and the user powered the device down shortly after.In the 10th session, the nav was powered on and paired to rs s/n (b)(6) and tka was performed.Tibia spirit angles displayed 0 degrees.The femur offset angles were measured at 3.08 and 9.05 degrees.The root cause of the failure was found to be a bug in the 4.22 sw that can cause inaccurate values.Software design improvements for the orthalign plus unit have been initiated to address this issue.

• Brand Name: ORTHALIGN PLUS UNIT
• Common Device Name: 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: 14824878
• Report Number: 3007521480-2022-00007
• Device Sequence Number: 17354564
• Product Code: OLO
• UDI-Device Identifier: 00851977007901
• UDI-Public: 00851977007901
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K103829
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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: 210731018LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown