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

Catalog Number ROB00043

Device Problems Image Display Error/Artifact (1304); Application Program Problem: Parameter Calculation Error (1449)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  Injury  

Event Description

It was reported that during a navio assisted surgery the navio surgical system japan image of tibia baseplate on planning screen was not displayed correctly.The image looked like halation was generated on tibia baseplate.The procedure was completed without delay, using manual procedure.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the navio surgical system japan, pn: rob00043, sn: (b)(6) used in treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.The software files were downloaded from the device and provided for investigation, however they did not contain any data and therefore could not be reviewed.It is possible that the files were not correctly copied onto the usb prior to sharing for investigation.Although the reported tibia baseplate halation on the planning screen could not be confirmed, it is possible that this is a known software bug, where the block model of the tibia is visible in certain implant positions on the planning screens.This can be corrected by translating or rotating the implant by 1 click.After translating/rotating the implant, the block model may appear again if the implant is moved back to that specific orientation.The navio surgical technique guide for knee arthroplasty (500200) provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines.¿ this situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• Brand Name: NAVIO SURGICAL SYSTEM JAPAN
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12044102
• MDR Text Key: 258977281
• Report Number: 3010266064-2021-00470
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556693667
• UDI-Public: 885556693667
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ROB00043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other