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

Model Number	403001-05
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	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time the product has not been returned for investigation.Once the product is returned orthalign will perform an investigation into the alleged accuracy issue.Orthalign is filing this mdr with an abundance of caution with the understanding of the potential harm that the patient could be subject to if the device produces inaccurate measurements.
Event or Problem Description
It was reported that total hip arthroplasty was performed with hipalign.Cup angles, especially abduction changed a lot after cup impaction.The anteversion angle also changed as well.He confirmed fixation of the unit and the reference sensor but no loose was found at that time.Subsequently, he completed the surgery with angles the navigation firstly showed.
Additional Manufacturer Narrative
A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.The root cause according to the nav unit operational log file is most likely due to the rs5 sensor unstable in comm check and the data received from the rs5 was abnormal.During functional testing, both the rs5 and nav.Unit worked as intended.Orthalign, inc.Will continue to monitor this issue and take action when/if alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: ORTHALIGN PLUS NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12059056
• Report Number: 3007521480-2021-00008
• Device Sequence Number: 19663931
• Product Code: OLO
• UDI-Device Identifier: 00851977007901
• UDI-Public: 00851977007901
• 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,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: Health Professional
• Device Model Number: 403001-05
• Device Catalogue Number: 403001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 09/10/2021
• Patient Sequence Number: 1