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

Model Number	133632
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2020
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 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.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.It cannot be determined how the reference sensor was assembled to the patient's tibia based on the contents of the event log, nor if this played any factor in the device output as reported by the user.The returned navigation unit and reference sensor were tested in-house.The two devices were tested by simulating a tka using saw-bones, performing a tibial and femoral navigations several times.All simulated usage passed, no issues were observed.The complaint cannot be confirmed based on the provided information.Orthalign, inc.Will continue to monitor this issue and take action when/if alert limits are exceeded.
Event or Problem Description
Inaccurate tibial alignment; the varus/valgus numbers displayed did not match actual alignment of the implant.

• Brand Name: KNEEALIGN 2 SYSTEM
• Common Device Name: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12302007
• Report Number: 3007521480-2021-00021
• Device Sequence Number: 20107930
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 02/04/2020
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1