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

Catalog Number NPFS02070

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/21/2018

Event Type  malfunction  

Event Description

It was reported that during a tka procedure, could not cut tibia as it said it needed more points, added more points but it wouldn't stop processing (it appears to be stuck) so last few points were removed and it still wouldn't stop processing. Then all the tibial points were cleared and started again. However, it would not let us proceed to cut the tibia using the 5mm spherical burr even after recalibration and checkpoint verifications. The error message "the system has detected that the navio app unexpectedly exited. Please contact robotics customer support to resolve this issue. " the case was aborted and converted to manual.

• Brand Name: NAVIO SURGICAL SYSTEM AU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; pittsburgh, pa ; 6833844
• MDR Report Key: 9993845
• MDR Text Key: 190180098
• Report Number: 3010266064-2020-00875
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

0 Patients were 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

• Device Catalogue Number: NPFS02070
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse