MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2; SURGICAL NAVIGATION SYSTEM

Model Number	133632
Medical Device Problem Codes	Material Discolored (1170); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer is reporting "something like blood" attached to the backside of the reference sensor.
Additional Manufacturer Narrative
At this time, the device is expected to be returned to orthalign for investigation, but has not yet been received.If the device is received, 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 lack of device cleanliness.
Additional Manufacturer Narrative
The reference sensor was returned to orthalign for evaluation.The investigation has been completed by an orthalign engineer.The complaint was confirmed.Lab investigations were performed to identify the root cause of the discoloration and analyze whether there was foreign material present.No foreign material was found and the root cause was deteremined to thernal degradation of the expoxy due to high temperatures when autoclaving resulting in the discoloration that was mistaken for blood.Orthalign will continue to monitor the complain data and take action if necessary.No further action is required at this time.
Event or Problem Description
Customer is reporting "something like blood" attached to the backside of the reference sensor and would like it tested.

• Brand Name: KNEEALIGN 2
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 153 technology dr; suite 100; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology dr; suite 100; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology dr; suite 100; irvine, CA 92618
• MDR Report Key: 18998663
• Report Number: 3007521480-2024-00005
• Device Sequence Number: 18244067
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 03/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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