MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO SURGICAL SYSTEM US; STEROTAXIC INSTRUMENT, COMPUTER ASSISTED

Catalog Number NPFS02000

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

Investigation narrative: the surgery took place on (b)(6) 2018 and the patient returned on (b)(6) 2018 with a fracture of the femoral shaft originating from the notch that occurred on (b)(6) 2018.Review of case screenshots, it can be seen on the place femur implant screen that the cut plane was set deeper than the anterior notch point and the surgeon and representative did not realize this at the time of the case.The yellow anterior notch point is visible in the planning screen, and it should not be visible if the cut plane is set to be flush to the notch point.This caused the implant to notch into the femoral shaft and created a stress riser that eventually led to a fracture.In this case, navio worked as expected and the implant placement did match with the planning done in navio.This was a result of poor planning and is a preventable issue caused by improper use.

Event Description

It was reported that the patient experienced a fracture on the femoral shaft two weeks post-operatively.

Event Description

It was reported that patient presented with femoral shaft fracture 2 weeks post operation.According to x-rays and screenshots provided, on the place femur implant screen, the cut pane was set deeper than the anterior notch point.The anterior notch point is visible in the planning screen and this caused the implant to notch into femoral shaft and created stress riser that eventually led to a fracture.

Manufacturer Narrative

H10, h3, h6: the device was used in treatment and it was reported a fracture on the femoral shaft 2 weeks post operation.Dhr review found that the software version has been validated.A complaint history review identified a prior similar event, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The surgical technique guide released at the time of the complaint provides instructions for proper free point collection, landmark collection, and implant placement.There are instructions for how to use the anterior notch point to prevent notching.We could confirm there was a relationship established between the reported event and the device.The log files and case screenshots were returned and evaluated.The surgery took place on (b)(6)2018 and the patient returned on (b)(6)18 with a fracture of the femoral shaft originating from that notch that occurred on (b)(6)2018.Reviewing of case screenshots, found that it can be seen on the place femur implant screen that the cut plane was set deeper than the anterior notch point and the surgeon and representative did not realize this at the time of the case.The yellow anterior notch point is visible in the planning screen, and it should not be visible if the cut plane is set to be flush to the notch pint.This caused the implant to notch into the femoral shaft and created a stress riser that eventually led to a fracture.Navio worked as expected and the implant placement did match with the planning done in navio.This was the result of a poor planning.The malfunction was due to user error.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Type of Device: STEROTAXIC INSTRUMENT, COMPUTER ASSISTED
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW; 2905 northwest blvd.; suite 40; plymouth MN 55441
• MDR Report Key: 7890847
• MDR Text Key: 120774156
• Report Number: 3010266064-2018-00014
• 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,Followup
• Report Date: 08/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention