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

Catalog Number NPFS02000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 04/17/2019

Event Type  malfunction  

Event Description

It was reported that during tka case, went to take knee center on the femur the navio threw up an error message about navio unexpectedly exited.Hit 'ok' on the error message to erase the message then 'resumed operation.' this brought up all the way back to the beginning and did not save previous information.Surgery started from the beginning.

Manufacturer Narrative

The device was being used during treatment when the case exited suddenly.The log files and case screenshots were returned for evaluation.The dhr was reviewed for software version (rc-6103) and it has been validated.A complaint history review found similar complaints of the reported issues and will continue to be monitored.The relationship of the device and the reported event has been established.The log files indicate that the system crashed while trying to enter femur free collection.The previous information was not saved because the first point where data is saved is after tibia free collection.Therefore, the root cause of the reported event was due to software failure.The software engineering team was made aware of the issue and are continuing to investigate.

• 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: 9994242
• MDR Text Key: 188813792
• Report Number: 3010266064-2020-01092
• 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: 08/26/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1