MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2; REFERENCE SENSOR

Model Number	133632
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation of the rs2 was performed.The reference sensor was able to pass back-table calibration without any issue using an in-house orthalign navigation unit.The reference sensor was subjected to forty-three simulated femoral maneuvers.The orientation of the reference sensor as well as the femoral length was adjusted after several data point were collected.The analysis shows that the reference sensor did not pass for the varus/valgus angulation; the flexion/extension performance was borderline, but still is considered passing.The complaint, as reported in the complaint description, details issues with the cut performed in extension.With regards to the extension angulation only, though the performance is marginal, the device operates as expected and no issues were observed with the accuracy of the reference sensor.The factory calibration of the reference sensor was assessed and found to be performed; no issues were observed in the testing of the reference sensor's factory calibration or dhr review.Though the performance of the reference sensor was not optimal for varus/valgus, the customer did not report any issue for this.With regards to the specific performance of the reference sensor for extension, the complaint cannot be confirmed based on testing performed.Some possible sources of error would include: the microblock assembly was not in the locked position during the femoral registration, or the user entered the wrong ap offset number while performing the left knee.The navigation unit used during the procedure was not returned to orthalign for investigation.Additional information was received from the customer regarding the stability of values shown.The customer reported that the values were "jumpy".This was observed during testing, but the displayed values jumped 0.5 degrees every few seconds.This is expected if the navigated value was in between a half of a degree value (such as 0.74 - 0.76), as minor fluctuations in the electronic signal and physical positioning of the system could either round up or round down by half of a degree.The customer did not specify if the displayed values varied significantly.Testing performed found the performance of the reference sensor, for this specific issue, acceptable per the design of the system.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.This initial report is being filed after the due date as the initial submission was found to have not be received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign inc of the issue prompting the submission of this as an initial report.
Event or Problem Description
It was reported that total knee arthroplasty (right and left knees) was performed with kneealign.After completed femur registration, the surgeon performed distal femur osteotomy by the adjusted angles.However, the femur bone was cut at over extension position.Subsequently, conventional instruments were used to complete the procedure.This incident occurred at left knee.

• Brand Name: KNEEALIGN 2
• Common Device Name: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12099225
• Report Number: 3007521480-2021-00013
• Device Sequence Number: 14450386
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 133632
• Device Catalogue Number: 133632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2019
• Initial Report FDA Received Date: 07/01/2021
• 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