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

Catalog Number ROB00036

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/16/2018

Event Type  Injury  

Event Description

It was reported that during tka case proceeded as usual, burred femoral cutting block and when moving to tibial burring, computer showed a grey screen and moved immediately to the case information screen.Then went through the process, moved from femoral screen to tibia, with the same result twice more.Completed the femur prep, aborted the navio and completed using standard instrumentation.

Manufacturer Narrative

H10 h3, h6: the device was used in treatment and case log files and screenshots were returned for evaluation.Dhr review found that the software version has been validated.A complaint history review found similar reports.This failure is an identified failure mode within the risk file.The surgical technique guide released at the time of the complaint provides recovery actions at different points of failure throughout the case in the recovery procedure guidelines section.Review of the log files confirmed that the software unexpected exited.The issue was caused by a poor bone mesh generation/point collection.The software was unable to resolve the surface into a bone model, causing it to crash.A relationship between the device and the reported event could be established.The probable cause of the issue was a software failure.

• Brand Name: NAVIO SURGICAL SYSTEM INDIA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2828 liberty ave; suite 100; pittsburgh, pa
• MDR Report Key: 9998170
• MDR Text Key: 189449882
• Report Number: 3010266064-2020-00807
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K180271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

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: ROB00036
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention