MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM; 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	02/05/2021
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.Abduction angle was incorrect.After surgeon set abduction angle 40 and 15 degrees, he installed a cup.Then, the navigation unit showed that the angle was 60 degree but image showed about 40 degree.
Additional Manufacturer Narrative
An investigation of the returned reference sensor and navigation unit was first performed by completing backtable calibration and simulated procedures on sawbones.No issues or anomalies were seen.Since the user described an accuracy issue with cup navigation, the units were tested to ensure proper outputs were received.The units were attached to a fixture with known dimensions and angles.All outputs were within the expected error bounds.Additionally, the navigation unit log file was inspected.The inspection revealed that during the procedure there was a high patient pelvic tilt and additionally either the pelvis or the pelvic base had moved over 10 degrees since initial registrations.These factors caused a high difference in the abduction between the table and anatomic frames which could have lead to confusion about the angles when comparing to intra-operative imaging.The high pelvic tilt angle could have contributed to the root cause of the perceived issue.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 11517178
• Report Number: 3007521480-2021-00004
• Device Sequence Number: 11797429
• Product Code: OLO
• UDI-Device Identifier: 00810832030072
• UDI-Public: 00810832030072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172462
• 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): 07/08/2021

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: 403001-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1