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

Catalog Number NPFS02000

Device Problem Computer Software Problem (1112)

Patient Problem No Information (3190)

Event Date 06/27/2014

Event Type  Injury  

Event Description

It was reported that system would not boot up prior to case.Error screen appeared and could not bring up splash screen.Ctrl alt f2 unable to bring up login screen to run logs and case was cancelled.

Manufacturer Narrative

H10: h3, h6: the device was used in treatment and it was reported that the system would not boot up.The software version was not recorded, but dhr review shows that all navio software versions released to the field have been validated.A complaint history review identified prior similar event, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The navio surgical system user's manual released at the time of the complaint provides instructions for the user in the "troubleshooting information" section.The point of failure for this case was during startup: "navio¿ surgical system fails to launch" and the solution was "contact smith & nephew robotics customer service".Accordingly, product labeling has been ruled out as a cause of the complaint.We could not confirm if there was a relationship established between the reported event and the device.The log files were returned for evaluation and the review revealed an error in communication between the cpu and ups (see photo in complaint folder).The nature of the error relates itself to the usb cable between the cpu and ups being damaged or disconnected in some way.Other possible causes could have been a bad usb receptacle on the ups, or a bad usb port on the cpu.Service was onsite and the system booted safely several times with no issues, thus reducing the probability of deficient components.The most likely explanation is an undetected disconnection in the usb cable caused the initial error(s).However, the ups, cpu, and usb cable were replaced for precautionary reasons.These results support that the most likely cause was that a usb cable was not fully seated.The root cause was undetermined after investigation.

• Brand Name: NAVIO SURGICAL SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; ste 40; plymouth, mn
• MDR Report Key: 9996833
• MDR Text Key: 188872272
• Report Number: 3010266064-2020-00149
• 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
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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?: No
• Device Operator: No Information
• 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