MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2; 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	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the device is expected to be returned to orthalign for investigation, but has not been recieved.If the device is recieved, an investigation will be performed to confirm the problem and determine the root cause, and a follow-up 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.
Event or Problem Description
"surgeon" is reporting cuts are way off and reference sensor is not giving any errors ir indications.No report of injury to patient.
Event or Problem Description
Surgeon reported cuts are way off and reference sensor is not giving any errors or indications.
Additional Manufacturer Narrative
The reference sensor was returned to orthalign for evaluation, but the navigation unit was unable to be returned.The investigation has been completed by an orthalign engineer.The behavior was not reproducable and the root cause was unable to be determined.The reference sensor passed all testing and no device defect was found.Orthalign will continue to monitor the complaint data and take action if necessary.No further action is required at this time.

• Brand Name: KNEEALIGN 2
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92656
• Manufacturer Contact: karyl haskell ; 120 colombia; suite 500; aliso viejo, CA 92656
• MDR Report Key: 18921773
• Report Number: 3007521480-2024-00003
• Device Sequence Number: 6201931
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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): 03/21/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown