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	Intraoperative Cardiac Valve Injury (4852)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure navigation unit made a long beeping sound and signaled to change battery in the reference sensor.After that the cuts may have been off.Procedure completed with traditional instrumentation.
Additional Manufacturer Narrative
At this time the device has been returned to orthalign for evaluation.An investigation will be completed by an orthalign engineer to attempt to confrim the complaint and determine a root cause.Upon the completion of the investigation a follow up report will be filed detailing the conclusions.
Event or Problem Description
During procedure navigation unit made a long beeping sound and signaled to change battery in the reference sensor.After that the cuts may have been off.Procedure completed with traditional instrumentation.
Additional Manufacturer Narrative
The reference sensor was returned to orthalign for evaluation, but the navigation unit was disposed of at the hospital.The complaint was unable to be confirmed since the reference sensor passed all functional testing and the navigation unit logs could not be reviewed.The root cause was unable to be determined but potential root causes include: user error, incorrect positioning of the instruments, or the cutting block moving during pinning.No further action required.

• Brand Name: KNEEALIGN 2
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology; irvine, CA 92618
• MDR Report Key: 20832908
• Report Number: 3007521480-2024-00020
• Device Sequence Number: 12918577
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/03/2025

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
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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