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)

Patient Problem Osteolysis (2377)

Event Date 02/01/2016

Event Type  Injury  

Event Description

It was reported that the patient presented with stress shielding and tibial osteolysis at the 5th post-operative assessment.No additional intervention performed at this time.

Manufacturer Narrative

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.The final implant placement location is defined by the surgeon's expertise and the navio system is only intended to assist in evaluation of placement accuracy.The fundamentals of stress-shielding are dependent on adequate loading of the remaining cortical bone.This is directly related to the final implant placement location and the patient's natural anatomy, determined by the surgeon.Futhermore, stress-shielding has the potential to be present in any implant based orthopedic surgery and this is the first instance that any suspicion of stress-shielding was possibly linked to navio, however there is no definitive connection to the navio system as outlined by the surgeon in the adverse event report form.

• 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; pittsburgh, PA 15222 ; 4126833844
• MDR Report Key: 7080815
• MDR Text Key: 93655169
• Report Number: 3010266064-2017-00019
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 06/13/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 63