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

Model Number	133632
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reported not being satisfied with the femoral resection due to possible miscalculation of v/v.Patien had to be taken back in for realignment after post-op x-ray.
Additional Manufacturer Narrative
At this time, the device in question has been requested to be returned for investigation.If the device are received, an investigation will be performed to confirm the problem and determine root cause, and 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 that is caused by device inaccuracy.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation and the investigation has been completed by an orthalign engineer.The behavior was not reproducable by the orthalign engineer.The reference sensor did not pass the ingress test and the root cause was determined to be water ingress.It is known that water ingress can short the reference sensor hardware.This issue is covered in orthalign's risk documentation.Orthalign will continue to monitor this issue and take action when alert limits are excceded.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation and the investigation was been completed by an orthalign engineer.Additional testing and an update of the investigation was performed.This additional investigation found that the behavior was not reproducable by the orthalign engineer and that the root cause is unknown.No device defect was found and it was concluded that the device did not contribute to the event.Orthalign will continue to monitor this issue.No other action is necessary at this time.

• Brand Name: KNEEALIGN
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92646
• Manufacturer Contact: karyl haskell ; 120 colombia; suite 500; aliso viejo, CA 92646
• MDR Report Key: 18270454
• Report Number: 3007521480-2023-00021
• Device Sequence Number: 17117054
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 10/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 133632
• Device Catalogue Number: 133632
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 11/29/2023; Not provided
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/15/2024; 10/08/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown