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

Model Number	403001-04
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	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation of the event log found that the user first performed the femoral maneuver and received a maneuver-too-slow error.The second two attempts produced results (based on the estimated hip vector) similar to one another.There is no indication, as reported in the event log, of system inaccuracy.The returned navigation unit was tested in-house with the returned reference sensor by simulating a tibial and femoral maneuver several times.All tested attempts found no issues with the devices.No issues were found with either the navigation unit or the reference sensor.The microblock assembly was examined.All devices, both returned in the complaint, and in-house to orthalign, were able to connect and interface to it without issue.No parts or linkages were observed to be loose.The assembly itself is intact with no observations in loose or missing parts.The returned knee calibration bracket was able to complete back-table calibration successfully with the returned devices; no issues were observed with the back-table calibration.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.This initial report is being filed after the due date as the initial submission was found to have not be received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign inc of the issue prompting the submission of this as an initial report.
Event or Problem Description
It was reported that total knee arthroplasty was performed with kneealign.The surgeon alleged that osteotomy angle for distal femoral was not proper.Subsequently, conventional instruments were used to complete the procedure.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: ORTHALIGN PLUS NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12097283
• Report Number: 3007521480-2021-00016
• Device Sequence Number: 11765689
• Product Code: OLO
• UDI-Device Identifier: 00851977007734
• UDI-Public: 00851977007734
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 403001-04
• Device Catalogue Number: 403001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 06/30/2021
• Patient Sequence Number: 1