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

Model Number	406000-02
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the device in question has been 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 conclusions.Orthalign reached out to the reporter to inquire for more information on the outcome of the procedure, but at this time there is not reason to believe that there was long-term harm to the patient.This report is being filed out of an abundance of caution and with an understanding of the patient harm that could be caused by device inaccuracy.
Event or Problem Description
Distal femur was calibrated and registered without incident or concern.Distal femoral cut was made and progressed to tibia without incident.It was observed that the extension gap was extremely tight.An addition 4mm was resected off the tibia and an addition 2mm off femur.Guide pins and spacer black were observed to be diverging into each other.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation.The investigation has been completed by an orthalign engineer.The reutrned instruments, rs, and nav unit passes functional testing without issue.The complaint event was found during reivew of the navigational log.The complaint is confirmend.The root cause can not be determined.It is suspected that the microblock was not sufficiently pinned, allowing the microblock to shift after completion of the femoral maneuver, during removal of the rs/nav units.Orthalign risk documentation addresss the risk ofnot securing the microblock to the femur as a potential user error.Due to its remote nature and low risk profile, no futher actions or mitigation is required.

• Brand Name: LANTERN SURGICAL ASSISTANT, NAV UNIT
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo 92646
• Manufacturer Contact: karyl haskell ; 120 colombia; suite 500; aliso viejo, CA 92646
• MDR Report Key: 17560690
• Report Number: 3007521480-2023-00011
• Device Sequence Number: 12023335
• Product Code: OLO
• UDI-Device Identifier: 00810832031567
• UDI-Public: 00810832031567
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 406000-02
• Device Catalogue Number: 460000-02
• Device Lot Number: 2304077LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention; Other
• Patient Sex: Unknown