MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM; REFERENCE SENSOR 2

Model Number	133632
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial report is being filed after the due date as the initial submission was found to have not been 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 initial report.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.The reference sensor and navigation unit was tested in-house by simulating a femoral maneuver using saw-bones.No issues were observed with the performance of the system.The microblock was inspected and no defects were observed.The error may reside in the user's fixation of the microblock at an initial, biased rotation, which may have provided an exaggerated measurement to the clinician.An investigation of the event log was performed.The event log reported that the user encountered difficulty in completing the femoral maneuver the first few times, but the user was able to complete the maneuver eventually.Orthalign will continue to monitor this issue and take action if or when/if alert limits are exceeded.
Event or Problem Description
It was reported that total knee arthroplasty was performed with kneealign.After maneuver leg at femur registration, surgeon adjusted angles.However, cut block position was obviously too valgous.Surgeon removed the fixation pins and inserted them to fix the cut block again.However, the same problem occurred again.Subsequently, conventional instruments were used to complete the procedure.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: REFERENCE SENSOR 2
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12284927
• Report Number: 3007521480-2019-00025
• Device Sequence Number: 14726940
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: No Information
• Device Model Number: 133632
• Device Catalogue Number: 133632
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1