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

Catalog Number NPFS02000

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  Injury  

Event Description

It was reported that in tka case, when it was time to bur the tibia cutting block peg holes, there were no holes to bur on the screen.Surgeon used the manual cutting block with the bone checker from the navio to place and pin the block.

Manufacturer Narrative

The navio surgical system was used in treatment and case log files and screenshots were returned for evaluation.Dhr review found that the software version (navio 6.1) has been validated.A complaint history review found similar reports and this issue will continue to be monitored.The navio surgical system: surgical technique for total knee arthroplasty was reviewed and it has figures and steps outlined to manipulate the orientation of tibia.Additionally, product labeling has been ruled out as a cause of the complaint.This failure is captured in the navio risk profile.The navio surgical system logs were returned for evaluation and an initial visual inspection confirmed the reported problem.Review of the screenshots found that the tibia twin peg was selected and that the holes visible were on the tibia to cut.It is likely that when the user first entered the cut tibia stage, the holes were not immediately noticeable because the initial view of the screen is to see the condyles, looking straight onto the tibia.In order to see the peg holes, the tibia must be rotated, as they are on the side.The screenshots also show that eventually the tibia view was rotated and the peg holes were cut.This was an expected behavior of the system.The root cause of this issue was determined to be insufficient operator training.

• 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: 9993878
• MDR Text Key: 188837036
• Report Number: 3010266064-2020-00881
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR