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

Catalog Number NPFS02070

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/21/2018

Event Type  malfunction  

Event Description

It was reported that during a tka procedure, could not cut tibia as it said it needed more points, added more points but it wouldn't stop processing (it appears to be stuck) so last few points were removed and it still wouldn't stop processing.Then all the tibial points were cleared and started again.However, it would not let us proceed to cut the tibia using the 5mm spherical burr even after recalibration and checkpoint verifications.The error message "the system has detected that the navio app unexpectedly exited.Please contact robotics customer support to resolve this issue." the case was aborted and converted to manual.

Manufacturer Narrative

H10.H3, h6: the device was intended for use in treatment and it was reported that after distal burring, checkpoint verification indicated that the checkpoint had moved 37mm and checking the 4 in 1 block position points showed that there was an inaccuracy of about a knee width.Resetting the checkpoints did not rectify this.Dhr review found that the software version has been validated.A complaint history review identified similar events.We could confirm there was a relationship established between the reported event and the device.The log files were evaluated.Review of the log files found that at checkpoint verification after distal burring the femur checkpoint had moved 22.88mm and then 99.62mm at the second verification attempt.It is likely that the tracker moved from the vibration of distal burring at the first checkpoint verification.The second checkpoint was verified from the tibia checkpoint when the software was checking for the femur, and it showed that the checkpoint had moved 109mm.109mm and 99.62mm are very close, and the values would depend on the initial tibia tracker and checkpoint placement.The reporter noted that resetting the checkpoints did not fix the issue.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, resetting the checkpoints is not the solution.If the checkpoints are reset for the femur, the user needs to go through registration with the femur again (free collection, implant planning, refining, etc.).This was a preventable issue.The malfunction was due to insufficient operator training.

• Brand Name: NAVIO SURGICAL SYSTEM AU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993845
• MDR Text Key: 190180098
• Report Number: 3010266064-2020-00875
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02070
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1