MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO

Model Number NPFS02000

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Joint Swelling (2356); No Code Available (3191)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

Investigation narrative: the surgical questionnaire on the adverse event form noted that the issue was "possibly" related to the navio or the implant but also noted that it was "possibly" unrelated to the study. The navio¿ surgical system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, and assists in preparation of bone cuts, based on prosthesis plan, taking into consideration 3d bone anatomy and ligament structures. Evaluation of the system archive and screenshots of the patient's procedure indicates that the planned locations of the implant, the predicted gap/ligament balancing and leg alignment are consistent with the post op results. Therefore the navio system performed as expected (i. E. The planned outcome aligns with the achieved outcome). Furthermore, the patient's relevant medical history shows a previous left hamstring tear which is the same hamstring that was irritated and ultimately caused the decision to perform a tka revision.

Event Description

It was reported that the patient experienced hamstring irritation and ischial tuberosity bursitis that resulted in revision surgery to a total knee arthroplasty.

• Brand Name: NAVIO
• Type of Device: STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW; 2905 northwest blvd.; suite 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; ste. 40; plymouth MN 55441
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; mn, PA 15222 ; 4126833844
• MDR Report Key: 7080653
• MDR Text Key: 115958402
• Report Number: 3010266064-2017-00018
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/17/2020
• 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: Unkown

Patient Treatment Data

Date Received: 12/04/2017 Patient Sequence Number: 1