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

Catalog Number NPFS02000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 09/10/2018

Event Type  Injury  

Event Description

It was reported that once on the place implant screen, the initial placement on the tibia implant had it at 15 degrees of external rotation.Able to place the tibia in a normal position and proceed with gap planning but the surgeon lost confidence in navio and decided to proceed manually.

Manufacturer Narrative

H10, h3, h6: the navio surgical system was intended for use in treatment and case log files and screenshots were returned for evaluation.Dhr review found that the software version (navio 6) has been validated.A complaint history review found similar reports and this issue will continue to be monitored.The navio surgical system for total knee arthroplasty user's manual was reviewed and it has information regarding tibia implant planning and resetting position.Additionally, product labeling has been ruled out as a cause of the complaint.This failure is captured in the navio risk profile.Review of the case screenshots confirmed the problem and found that tibia free collection was taken 3 times.The first two times, the mesh did not show, indicating poor collection.After the second time, the implant was placed and planned and then the user recollected the free points, tubercle, and landmarks for the tibia.Since everything was recollected, there was a warning message, "the landmarks have been changed since the plan was last reviewed", which indicates that the plan will no longer match up with the bone.Therefore, when the user dismissed the error and went back into "place tibia implant", the implant appeared to be rotated 15 degrees off of the bone and completely incorrect.However, this was an expected behavior of the system, since the implant placement was still aligned to the original landmark collection.This could have been mitigated by selecting "reset position" on the "place tibia implant" screen.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: 9993781
• MDR Text Key: 188794777
• Report Number: 3010266064-2020-00869
• 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

• Date FDA Received: 04/23/2020
• 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
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention