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

Catalog Number NPFS02000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 06/22/2020

Event Type  Injury  

Event Description

It was reported that during a tka procedure, when they burred the tibia cut block post holes, the medial side did not provide enough stability for the block, so they burred the entire tibia (this was done on exposure then speed control to clean up).When it was completed, they used the visualization tool to confirm the accuracy and it was way off showing a valgus cut with too much slope.The checkpoints were verified and the trackers had not moved.They moved forward to trialing and the outcome was awful, it was in 5 degrees at least of varus, opposite of what the system was saying, but there was a lot of extra slope like they had seen and they had to adjust for as well (the tibia was recut with manual instruments).The handpiece tracker was checked and tight, the drill was locked in along with the burr and long attachment.The visualization tool was also locked in place.This caused a delay of more than 30 minutes.

Manufacturer Narrative

H3, h6: the navio surgical system us, pn: ornpfs02000, 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 product was not returned however the software files were downloaded from the device and provided for investigation.The screenshot review could not confirm the complaint.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.This case was put in casevisualizer, where it was confirmed that the checkpoints were on the bone, which rules out tracker movement.The screenshots show that the checkpoints passed.The tibia cut selection screen shows a portion of the cut guide¿s post showing through the top of the tibia on the medial side.When in tibia bone removal, the user did go back and forth between speed and exposure mode.However, the tibia was not entirely burred to the target surface prior to visualizing the cut.The ridge of the posterior side as well as a portion of the anterior had not been resected.The live read-out of the tibial slope shows a 2.3 degree valgus angle.It cannot be confirmed that, when in trialing, the knee was in 5 degrees of varus.It is possible that when using the plane visualization tool that the plate was lying on a portion of unresected bone, and not flat bone.It is also possible that the unresected portion of the bone had been resected with manual instrumentation, and therefore was not visually represented on the screen.The user may have cut more deeply than intended, creating a varus tibial slope.The navio user¿s manual contains a table describing the navio's color-coding display that identifies bone regions and indicates the amount of bone to be removed.During the bone removal stage, white indicates that the target surface has been reached.Bone to be removed changes colors based on its thickness.If bone is cut deeper than called for by the plan, the system highlights this region in red.As bone is removed, the onscreen model indicates the depth of the cut.The goal is to cut through the colored layers of bone until the white target surface is revealed.The surgical technique guide instructs the user to update the virtual bone model in refine mode if manual instrumentation, such as rasps, are used for bone preparation at any time.Refer to the surgical technique guide for the use of the plane visualization tool.This tool can be used after bone removal to visualize the actual cut prepared.This situation was captured in the navio risk assessment released at the time of the complaint.As a result of these findings, it was determined that the software functioned as intended; no defect of the system occurred.Based on the investigation, no containment or corrective actions are recommended 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 55441
• MDR Report Key: 10280693
• MDR Text Key: 199050774
• Report Number: 3010266064-2020-01661
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention