MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02000

Device Problem Poor Quality Image (1408)

Patient Problem Injury (2348)

Event Date 03/29/2019

Event Type  Injury  

Event Description

It was reported that during ukr case in the component position screen, the colored dots on the tibia were floating next to the tibial component.Doctor switched to manual procedure.

Manufacturer Narrative

H10: the device was used in treatment.Case log files and screenshots were returned for evaluation.Device history record review found that the software version 6.1.03 has been validated.A complaint history review identified prior similar events, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The navio system instructions for use released at the time of the complaint provides instructions for the user in the intraoperative procedures section regarding landmark point selection.Note: if you press collect (hold) before placing the point probe tip on the condyle, the camera will collect outlier points.While these outlier points do not affect calculations, they do not represent the bone surface and may be misleading.You can avoid outlier points by placing the point probe tip on the condyle before pressing collect (hold).We could confirm there was a relationship established between the reported event and the device.Review of the log files and case screenshots confirmed that the reported event was not related to tracker movement, but is related to how the landmark points were initially taken.In the planning screens, the initial placements of the implants are based on how the landmark points are taken as a guide and it is the surgeon's responsibility to properly adjust and place the implant.Per complaint details, currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, the procedure change/subsequent modified procedure, did not result in a procedural delay or patient injury/impact; therefore, no further medical assessment is warranted at this time.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9994239
• MDR Text Key: 188804346
• Report Number: 3010266064-2020-01088
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention