MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110137

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/06/2020

Event Type  Injury  

Event Description

It was reported that, during a navio tka procedure, during bone removal on the femur, the bur was removing bone deeper (beyond the planned depth) for the planned distal cut on the femur.As the surgeon recognized the discrepancy in cut depth, he checked that the drill and burr were both properly locked into the handpiece.At that point, he discontinued burring the distal femur, and finished with a cut block and saw blade, navigated with the visualization tool.No error message indicated during the initial set up and calibration of the handpiece and drill.The tip of the bur was set at the correct depth within the exposure guard.Following the procedure, they checked the handpiece and drill for loose assembly, but none was observed.The markers and tracker were checked, but they were installed correctly as well.They performed a drill test and hand piece test following the case.No errors detected with the drill.The procedure was resumed by using the navio system, but only for the navigation feature to set manual cut blocks.The patient outcome is unknown.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the navio risk profile.The navio user's manual (500196) contains instructions for proper handpiece assembly in the "assembling the hardware" section and handpiece testing in the "performing handpiece diagnostics" section.The navio surgical technique guide (500197) provides instructions for reverting to a manual procedure at any point in the case in the "recovery procedure guidelines" section.A relationship, if any, between the subject device and the reported event could not be determined.A factor that could have contributed to the reported event could be if the drill was not properly seated in the handpiece or if the bur size selected on the system was not the same as the bur size being used.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.The medical investigation found that this complaint reports issues with the navio system procedure during the cutting/burring the surgeon recognized the discrepancy in cut depth, he checked that the drill and burr were both properly locked into the handpiece.At that point, he discontinued burring the distal femur, and finished with a cut block and saw blade, navigated with the angle visualizer tool.No error message indicated during the initial set up and calibration of the handpiece and drill.It has been communicated that the operative reports would not be forthcoming.The actual bone was cut deeper on the distal medial cut as indicated on the virtual bone/screen.The exposure guard/control were not restricting the amount of bone resected.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10480834
• MDR Text Key: 205261085
• Report Number: 3010266064-2020-01744
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• 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
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention