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

Catalog Number NPFS02000

Device Problems Display or Visual Feedback Problem (1184); Image Orientation Incorrect (1305)

Patient Problem Injury (2348)

Event Date 04/16/2019

Event Type  malfunction  

Event Description

It was reported that during tka case, check points were evaluated and then proceeded to distal femur bur. Completed bur process with zero red color indicator present. Once 5-1 block was placed on femur and screen switch to visualized cut. A huge misalignment was noticed in the rotational view (bottom left view) with visual guide inserted in anterior cut slot (8-10) degrees. All other two measurements were inside 1mm of corrections. Screen was switch back to bur initial cut and when handpiece was brought back on field of view, femur was painted dark red. At this point, the checkpoint button was pressed to re-evaluate check points. Navio stated femur checkpoint was off 20mm. Tibia checkpoint cleared. Case proceeded with manual angel wing for cuts. All femur cuts with 5-1 block were accurate despite navio stating block was rotated 8-10 degrees off.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2828 liberty ave; suite 100; pittsburgh, pa
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; pittsburgh, pa ; 6833844
• MDR Report Key: 9994236
• MDR Text Key: 188837517
• Report Number: 3010266064-2020-01091
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

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

• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/24/2020 Patient Sequence Number: 1