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

Model Number	403001-08
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	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time the product has been returned for investigation.Once the investigation into the alleged accuracy issue is performed a follow up submission will be filed.With an abundance of caution this report is being filed with the understanding of the potential patient harm that could be caused to the patient by an inaccurate device measurement.
Event or Problem Description
It was reported that during cup positioning the read out of numbers seemed to be the opposite of what the surgeon was doing.They double checked that the correct side was selected and that the impactor adapter was facing the correct direction.No adverse event was reported.
Additional Manufacturer Narrative
The investigation was not able to reproduce the alleged behavior, although the navigational logs did confirm the unexpected values reported by the user.While the root cause cannot be determined, it is suspected to be user error, as the failure event could only be replicated when the incorrect hip was selected by the orthalign engineer.

• Brand Name: ORTHALIGN PLUS UNIT
• 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 ; 9497152424
• MDR Report Key: 15490171
• Report Number: 3007521480-2022-00012
• Device Sequence Number: 1885343
• Product Code: OLO
• UDI-Device Identifier: 00810832031369
• UDI-Public: 00810832031369
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200642
• 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,Followup
• Report Date (Section B): 06/20/2023

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: 403001-08
• Device Catalogue Number: 403001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Sex: Unknown