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

Catalog Number NPFS02070

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

The log files and case screenshots were reviewed and evaluated.We confirmed that the initial implant size was a size 7 femur.The surgeon then changed to a size 5n femur in planning and there was a notching warning.The notch point was being taken from extrapolated bone model, so we cannot be confident that it will notch, even with the warning.The final plan was a size 5n femur and a size 4 tibia and the surgeon cut to these sizes.The navio 7 software initially places the implant, first with the smallest implant size.The software then increases the size of the implant, one size at a time, until it finds the femur size that does not notch anteriorly, based on the notching region defined by navio.Navio does not look at the medial/lateral aspects of the defined bone or factor it into implant sizing.The notching region referenced is located 20mm proximal to the most superior aspect of the implant design.This region can be defined on either the high-confidence mesh defined by the surgeon, or the model generated by the system.In the defined region as described above, if navio finds that the implant placement and size selected is below the surface model, even at a singular point, the notch warning indicator turns on.It is recommended to paint the defined anterior cortex region, as noted by the light grey outline on the bone model in free collection.The notch warning could have been addressed by flexing the component in place instead of changing the placement in order to optimize the location based on flexion, within clinically acceptable boundaries.After review of the screenshots, it was determined that navio functioned as expected in the initial implant sizing step with the input data from bone registration.Navio provides an initial size and it is the surgeon's responsibility to adjust the size and position of the implant based on their discretion and preferences to best fit the patient.The surgeon followed the correct steps in changing the implant size.

Event Description

It was reported that software oversized implant by approximately 2 sizes.Initially sized at 7 when patient required a 5 narrow.Software also indicated notching and it was not the case when checked by surgeon.Delay of less than 30 minutes reported.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The log files received from the system confirm that surgery was completed with navio and femur was downsized during planning and no additional cuts were required to complete the surgery since the size was defined prior to cutting; therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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 55441
• MDR Report Key: 9536576
• MDR Text Key: 188506174
• Report Number: 3010266064-2019-00152
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K180271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02070
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1