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

Catalog Number NPFS02000

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 04/01/2019

Event Type  Injury  

Event Description

It was reported that during tka case surgeon went to cut the tibia and noticed that the bone model exposed red indicating the drill was loose.Surgeon pushed plan button to reposition the bone model while the surgical tech reassembled the handpiece and drill.Immediately got a handpiece error on the screen.Proceeded to recalibrate and was given the handpiece error again.Did this process at least 4 times and was unable to get rid of the handpiece error screen.Did attempt to unplug the handpiece and plug back in as well.Case was completed as a manual procedure.After the case, ran 3 handpiece tests and passed with 20 and under.

Manufacturer Narrative

H10: the device was used in treatment.Case log files and screenshots were returned for evaluation.Dhr review found that the software version 6.0.01 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 (pn 500097 rev e) provides instructions for the user that "if at any point during the procedure, you observe that the handpiece tracker frame has become loose, tighten the tracker frame to the handpiece and recalibrate the handpiece.Fine adjustments can be made using the t-wrench.The twrench can prevent tracker movement by ensuring it is fully tightened.The navio system instructions for use also states the responsibility of the surgeon with regards to navio system use.Accordingly, product labeling has been ruled out as a cause of the complaint.We could confirm there was a relationship established between the reported event and the device.Review of the log files and case screenshots found that in the checkpoint verification step before beginning cutting, verification failed and the checkpoints were redefined.The tibia tracker likely moved after registration and implant planning but before cutting.Then, when the user went to cut the tibia, even though the bur was not yet on the bone, the system thought it was because the physical location of the bone did not match what was on the system and showed as an overcut, red portion.Redefining the checkpoint does not realign the setup with the previous cut plan and should not be done unless it can be confirmed that neither tracker has moved.Therefore, if a tracker has moved, redefining the checkpoints is not the solution.If the checkpoints are reset, the user needs to go through registration again (free collection, implant planning, refining, etc.).It was also noted that the drill was loose.Red on the bone model indicating an overcut could mean that the drill was loose, however the case screenshots and log files confirmed that this was due to the trackers moving.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: 9994245
• MDR Text Key: 188805019
• Report Number: 3010266064-2020-01087
• 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