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

Model Number	403087-06
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	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon positioned the cup per the technique.The first time cup was registered with no incident.The second time the cup was registered it started at a normal value but then quickly started to drift away to different values.The drift was likely 10 degrees of anteversion before the 30 second timer ended.The third time the drift was not present.
Additional Manufacturer Narrative
The reference sensor powered up and successfully passed horizontal, vertical, and side calibration.The sensor also successfully completed multiple simulated maneuvers during testing.The reference sensor was found to function as design.It is suspected that the root cause of the failure is a power failure within the navigation unit.The navigation unit was opened for inspection and it was found that one of the batteries had visible burn marks on the "positive" end, and the battery connector had burn marks as well.This can cause the unit to not perform as expected.There is no navigation log available for review.No fault could be found with the returned reference sensor 5 unit.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign will continue to monitor this issue and take action if or when alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: REFERENCE SENSOR
• 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
• MDR Report Key: 15200205
• Report Number: 3007521480-2022-00008
• Device Sequence Number: 15015711
• Product Code: OLO
• UDI-Device Identifier: 00851977007888
• UDI-Public: 00851977007888
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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: 403087-06
• Device Catalogue Number: 403087-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown