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

Catalog Number NPFS02000

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problem Injury (2348)

Event Date 05/09/2019

Event Type  Injury  

Event Description

It was reported that during tka case, while preparing to map the femur, the system flipped to a white screen and a black box was displayed with the 800 number to call.Case was aborted and completed as a manual procedure.

Manufacturer Narrative

H10: the device was used during treatment when case exited suddenly.The log files and case screenshots were returned for evaluation.Dhr review found that the software version (navio rc-6103) had been validated.A complaint history review found similar complaints of the reported issue and it will continue to be monitored.This failure has been identified in the risk file.The surgical technique guide released at the time of the complaint (pn (b)(4)) provides instructions that cover in the event of system crash.The relationship of the device and the reported event has been established.Review of the log files confirmed that the system crashed after entering femur free collection and collecting a couple of points.Therefore, the root cause of the reported event was due to software failure.This issue is being investigated by the software engineering team.Per complaint details, the device malfunctioned during set-up; while preparing to map the femur, the system flipped to a white screen and a black box was displayed with the 800 number to call.Based on the information provided, there was no patient injury/impact as the procedure was completed with manual instrumentation.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: 9994254
• MDR Text Key: 188813724
• Report Number: 3010266064-2020-01100
• 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?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR