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

Model Number	401612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the device in question has be requested to be returned for investigation, if the device is received, an investigation will be performed to confirm the problem and determine root cause, and a follow-up report will be filed detailing the conclusion.This report is being filed out of an abundance of caution and wiht an understanding of the patient and/or user harm that could be caused by broken, sharp parts.
Event or Problem Description
Tibial cutting block has a piece of damaged metal sticking off of it that is sharp.
Additional Manufacturer Narrative
The device in question was not returned for investigation.An investigation was completed based on a photograph of the issue reported.Based on the photograph the complaint was confirmed but the root cause could not be determined.This report is being filed out of an abundance of caution and with the understanding of patient/user harm that could occur from sharp metal.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; 153 technology dr; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology dr; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology dr; irvine, CA 92618
• MDR Report Key: 19566956
• Report Number: 3007521480-2024-00008
• Device Sequence Number: 6141035
• Product Code: OLO
• UDI-Device Identifier: 00858704006329
• UDI-Public: 00858704006329
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/21/2024

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: 401612
• Device Catalogue Number: 401612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown