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

Model Number	402042
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time the device has been requested to be returned to orthalign for evaluation by an orthalign engineer.If the device is received an investigation will be conducted to confirm the complaint and determine a root cause fi possible.Upon completion of the investigation a follow up report will be filed detailing the conclusion.No further action required at this time.
Event or Problem Description
A small burr was found on the shaft of a new microblock.Another microblock of the same lot was checked and it also had a burr.
Additional Manufacturer Narrative
The part was not returned to orthalign for an investigation but in house parts from the same lot with the same burr were investigated by an orthalign engineer.The complaint was confirmed and the issue was found to be due to a machining defect.Orthalign followed up with the vendor and updated inspection plans to inspect for this manufacturing defect and documentation was updated to identify as a new risk.No medical event occurred where a burr fell into a wound and the medical benefits outweigh the residual risk.No further action required at this time.
Event or Problem Description
A small burr was found on the shaft of a new microblock.Another microblock of the same lot was checked and it also had a burr.

• 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: 21103132
• Report Number: 3007521480-2025-00001
• Device Sequence Number: 9154998
• Product Code: OLO
• UDI-Device Identifier: 00858704006336
• UDI-Public: 00858704006336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 402042
• Device Catalogue Number: 402042
• Device Lot Number: 23120402Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown