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

Model Number	402042
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Metal Related Pathology (4530); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question has been returned to orthalign for investigation.The investigation was completed by an orthalign engineer.The complaint is confirmed based on visual verification of physical damage and discoloration to the hole of the microblock.The root cause was determined to be the threaded pin not remaining in a straight line during the duration of use causing galling between the metals.This report is being filed out of an abundance of caution and with an understanding of patient harm that could occur if a pin were to become stuck.Orthalign will continue to monitor the complaint data and take action if necessary.No further action is required at this time.
Event or Problem Description
The surgeon reported that the treaded pin interfered with the pin hole of the micrblock and jammed in the pin hole due to pin eccentricity during drilling.
Event or Problem Description
The threaded pin jammed in the pin hole of the microblock.This caused metallosis.
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 caused by this issue.

• 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: 19702151
• Report Number: 3007521480-2024-00009
• Device Sequence Number: 15451476
• Product Code: OLO
• UDI-Device Identifier: 00858704006336
• UDI-Public: 00858704006336
• 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): 09/04/2024

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: 402042
• Device Catalogue Number: 402042
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/04/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown