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 11/16/2016

Event Type  malfunction  

Event Description

It was reported that during case, received an error causing to lose the colored bur targets for tibial cut block.Tried moving the tibial implant superior by 1 click and advanced back to the cut screen to reset the model but it did not work.Doctor decided to restart the case, create a new patient and case was finished without any other problems.

Manufacturer Narrative

H10: the navio surgical system, used in treatment, received an error which caused the loss of colored bur targets for tibial cut block, during a procedure on (b)(6) 2016.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 found similar reports and this issue will continue to be monitored.The navio surgical system logs were not returned for evaluation and an initial visual/functional evaluation could not be performed.The reported problem could not be confirmed.The root cause of this issue was found to be undetermined.No corrective actions were initiated for this issue.Factors that could have contributed to the issue was if it was a known bug where the color mapping for the cut guide post holes do not appear on the model.If this error occurs again, a few troubleshooting tips that can correct the error are to quit the case and re-enter, move the cut guide location as little as one click laterally, and reenter cutting.If that does not resolve the issue, the case can be quit and restarted with a new patient file.If this was the issue, the bug has been corrected on the next software release.

• 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: 9989185
• MDR Text Key: 188654560
• Report Number: 3010266064-2020-00343
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1