MAUDE Adverse Event Report: ORTHALIGN, INC. LANTERN SURGICAL ASSISTANT; SURGICAL NAVIGATION SYSTEM

Model Number	402472
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the device in question has been requested to be returned for investigation and that request has been denied.Zimmer biomet japan has indicated an intention to continue using the device since they were unable to duplicate the event.This report is being filed to document the unwillingness to return the device and the intention to continue using a device associated with a fda reportable event.Orthalign acknowledges and understands the risk for patient harm with continued use and will continue to request the device be returned for evaluation.
Event or Problem Description
The paddles on the balance femoral paddle instrument did not move smoothly and the gap values were less than the surgeon expected.Zimmer biomet unable to duplicate the reported issue and is unwilling to return the requested instruments and may continue to use them until orthalign provides replacements.
Additional Manufacturer Narrative
The part was returned to orthalign for evaluation.The investigation has been completed by an orthalign engineer.The complaint was confirmed.A possible root cause was identified as an issue with tolerance stack up.Orthalign will continue to monitor this issue and take action when alert limits are reached.No further action is needed at this time.
Additional Manufacturer Narrative
At this time, the device in question has been requrested 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 conclusions.This report is being filed out of an abundance of caution and with an understanding of the paitent harm that could be caused by device inaccuracy.
Event or Problem Description
The paddles on the balance femoral paddle instrument did not move smootly and the gap values were less than the surgeon expected.

• Brand Name: LANTERN SURGICAL ASSISTANT
• 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: 19396219
• Report Number: 3007521480-2024-00007
• Device Sequence Number: 20771864
• Product Code: OLO
• UDI-Device Identifier: 00810832031482
• UDI-Public: 00810832031482
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200892
• 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,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: 402472
• Device Catalogue Number: 402472
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/07/2024; 08/22/2024
• 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
• Patient Sex: Unknown