MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN2 - REFERENCE SENSOR; SURGICAL NAVIGATION SYSTEM

Model Number	133632
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	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported tthat total knee arthroplasty was performed with kneealign2 on (b)(6) 2023 and the cutting block positioned in largely valgus, although the kneealign femoral side was set to 0 degree varus/calgus and 3 degrees of flexion.
Additional Manufacturer Narrative
At this time, the devices in question have been requested to be returned for investigation.If the devices are received, an investigation will be performed to confirm the problem and determine root cause, and a followup report will be filed detailing the conclusions.This report is being filed out of an abundance of caution and with an understanding of the patient harm that could be caused by device inaccuracy.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation.The investigation performed by the orthalign engineer was not able to replicate the reported event.No issues were found with the returned reference sensor.The used nav unit was not returned so the navigation log is unable to be acquired.The complaint can not be confirmed and no root cause can be determined.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.

• Brand Name: KNEEALIGN2 - REFERENCE SENSOR
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; suite 500; aliso veijo CA 92646
• Manufacturer Contact: karyl haskell ; 120 colombia; suite 500; aliso viejo, CA 92646
• MDR Report Key: 17391005
• Report Number: 3007521480-2023-00010
• Device Sequence Number: 8942643
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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: 133632
• Device Catalogue Number: 133632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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