MAUDE Adverse Event Report: ORTHALIGN, INC. LANTERN SURGICAL ASSISTANT; NAVIGATION UNIT

Model Number	406000-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During investigation of returned reference sensor and navigation unit the tester user dialed in 5 degrees of extension and performed three hip point maneuvers, and subsequently dialed in 5 degrees of flexion and performed three hip point maneuvers.Each maneuver had 0.5 degrees of error or less.The test on the hip point verification fixture was repeated with an in-house orthalign plus unit and rs2.This test yielded a maximum of 1.0 degrees error from the expected value.An additional test on sawbones was performed to navigate the femoral resection plane to 3.5 degrees, as described in the complaint.The returned rs and navigation unit were paired and calibrated.Then a femoral maneuver was performed and the resection was dialed to 3.5 degrees of flexion.The orthalign engineer verified the image on the screen with the resection line matched the output.The engineer confirmed the cutting block was aimed in flexion, the software displayed flexion, and the resection line on the software image was also in flexion.Therefore, it can be concluded that the lantern navigation unit and reference sensor that were returned were able to navigate the femoral resection according to specification.The log files for the case were also reviewed and confirmed the user dialed in 3.5 degrees of flexion and 0 degrees of varus/valgus.However, no anomalies or errors were found in a review of the log file.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.
Event or Problem Description
It was reported that the surgeon dialed in 3 degrees of flexion but the implant came out 5 degrees of extension.No patient injury was reported.

• Brand Name: LANTERN SURGICAL ASSISTANT
• 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: 14402687
• Report Number: 3007521480-2022-00004
• Device Sequence Number: 5606800
• Product Code: OLO
• UDI-Device Identifier: 00810832031406
• UDI-Public: 00810832031406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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: Health Professional
• Device Model Number: 406000-01
• Device Catalogue Number: 406000-01
• Device Lot Number: 21111807LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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
• Patient Sex: Unknown