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

Model Number	403001-05
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An orthalign distributor reported that during a tka procedure a cut was performed and the cut was larger than the surgeon intended.This caused prolonged surgical time, but at this time there is no known injury to the patient.An investigation will be performed once the unit is returned from orthalign inc.'s distributor in (b)(4).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 and prolonged surgical time.
Event or Problem Description
It was reported that total knee arthroplasty was performed with knee align.When surgeon checked the patient's femur bone and distal osteotomy surface with image during surgery, he found that the valgus angle was too much.
Additional Manufacturer Narrative
The root cause could not be determined because the incorrect reference sensor was returned.The history of the nav.Unit was reviewed via the downloaded logs from its non-volatile memory.The event log showed there were many "hip search failed: slip detected" messages.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 when/if alert limits are exceeded.
Additional Manufacturer Narrative
Corrected data: h6 codes investigation findings: 3213, investigation conclusions: 44.During investigation a review of the event log found that there were several attempts to complete the femoral maneuver while paired with the reference sensor 2 sn (b)(6) but the procedure was not completed.Using an orthalign mechanically fabricated femoral platform, the returned navigation unit and reference sensor 2 were attached to the microblock and the femoral maneuver was performed.After the sensors were attached to the microblock, the position necessary to align the navigation target on the navigation unit screen resulted in an angle that was abnormally high.When the leg was aligned in a normal position, the target on the navigation unit screen was not reached.The returned navigation unit passed tests with the in-house reference sensor 2 unit to confirm accuracy, but failed the femoral maneuver when paired with the returned reference sensor 2 sn (b)(6).A functional test was performed on the returned navigation unit and an in-house reference sensor.The navigation unit successfully performed simulated procedures when paired to the in-house reference sensor.The navigation unit was found to function as designed.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
• 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 ; 8665820879
• MDR Report Key: 12010610
• Report Number: 3007521480-2021-00007
• Device Sequence Number: 4452674
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2021

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 Model Number: 403001-05
• Device Catalogue Number: 403001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 11/10/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/19/2021; 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown