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

Catalog Number ROB00036

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Injury (2348)

Event Date 08/28/2019

Event Type  Injury  

Event Description

It was reported that during surgery error appeared on the screen that " internal cable failure" and shutdown.After shutdown and restart error 40000000000 on screen.Surgery was completed as a manual procedure.

Manufacturer Narrative

The device was being used during treatment and was not returned for evaluation.There was no serial number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history review was performed and found 17 reports of the issue.This issue will continue to be monitored.The surgical technique guide released at the time of the complaint (pn 500095 rev#d) provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable., etc.Since the reported event was related to a component failure, there is no indication in this complaint that the user did not follow the ifu.A relationship between the device and reported event has not been established.A factor that could have contributed to the reported event was a short in the handpiece cabling that caused a blown fuse in the siu.However, without the device for evaluation, the reported event cannot be confirmed.Therefore, the root cause of the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.There was no major delay and therefore, no patient injury/impact to the patient; therefore, no further medical assessment is warranted at this time.

• Brand Name: NAVIO SURGICAL SYSTEM INDIA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN
• MDR Report Key: 9999315
• MDR Text Key: 189169115
• Report Number: 3010266064-2020-01406
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ROB00036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1