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

Model Number	403001-05
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An orthalign distributor reported that the first navigation unit that the surgeon attempted to use gave a flexion reading of 18 degrees.The surgeon noted that this is extreme and it is unable to have traveled that much.Orthalign's representative noted that this particular surgeon has done hundreds of cases and know this.Orthalign plus units have been cleared by the fda with the claim of +/- 3 degrees.An investigation will be preformed once the unit is returned from the field.With an abundance of caution this report is being filed with the understanding of the potential patient harm that could result from an accuracy malfunction of this magnitude.A follow up report will be filed with the investigation findings.
Event or Problem Description
Navigation unit ((b)(4)) gave a flexion reading of 18 degrees, this is extreme and unable to travel that much.
Additional Manufacturer Narrative
The navigation unit's event log was examined for the phenomenon reported in the complaint description.No flexion values were reported to have approached 18 degrees, though there was an issued observed during the femoral resection in general.The logged snapshot of resection values did not change between each snapshot, though it is expected that they would change in some minor degree between samples.The issued observed occurred after a period of reported instability on the reference sensor.The same phenomena occurred during the tibial resection as well.An attempt to reproduce this behavior in-house was unsuccessful for both femoral and tibial resections.It is unclear as to what was causing the bouts of instability; the reference sensor would be needed for further information but was unavailable for return.While the values reported in the complaint description cannot be found within the event log, the complaint can still be confirmed based on the other evidence present due to the issue regarding the resection angles not updating between samples.There was no patient consequence reported as a result of the event.A review of the device history record (dhr) was conducted.There was 1 process deviation (pd) within the dhr.The pd is 1480.There were no nonconforming material reports (ncmrs) within the dhr.The device passed all manufacturing specifications prior to release, and it is concluded that the issue in pd1480 did not contribute to the reported complaint.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 8584230
• Report Number: 3007521480-2019-00010
• Device Sequence Number: 16731537
• Product Code: OLO
• UDI-Device Identifier: 00851977007901
• UDI-Public: 00851977007901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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 Expiration Date: 12/31/2020
• Device Model Number: 403001-05
• Device Catalogue Number: 403001-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention