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

Model Number NPFS02000

Device Problems Calibration Problem (2890); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/09/2019

Event Type  Injury  

Event Description

It was reported that during second case, finished burring, but when checking cuts on the 5-1 block, the system showed the cuts being significantly off from original plan.Suggested to go back and check checkpoints again and the femoral checkpoint was off by about 11.8 millimeters.Doctor was adamant that the track arrays and checkpoints did not move and surgery was completed with manual instruments.Delay of less than 30 minutes was reported.

Manufacturer Narrative

H10: a1.H3: updated information.H11: b2, b5, g5, h6: corrected information.

Event Description

It was reported that, during a tka surgery, burring was already finished so the cuts made on the 5-1 block were checked: the system showed the cuts being significantly off from original plan.So the checkpoints were checked again and the femoral checkpoint was off by about 11.8 millimeters; however, this is approximately the off-distance when the tracker rolls off the ridge to the flat surface.It is unknown how this event was resolved.The patient outcome is unknown.

Manufacturer Narrative

H10, h6: the navio surgical system logs was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.The software version was not recorded, but dhr review shows that all navio software versions released to the field have been validated.A complaint history review found similar reports.The surgical technique guide released at the time of the complaint provides instructions for burring on the system.Accordingly, product labeling has been ruled out as a cause of the complaint.This failure is captured in the navio risk profile.A clinical/medical investigation noted that, the surgery was completed with manual instruments.There was a delay of less than 30 minutes.No harm to the patient was reported.No clinical/medical documentation was provided.Without supporting clinical/medical documents, a thorough investigation cannot be performed.The navio internal log will be reviewed if it reveals additional information and this complaint will be re-assessed.A relationship, if any, between the subject device and the reported event could not be determined.A factor that could have contributed to this issue is if the tracker was tightened on an edge and rolled to a flat during the case.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9258177
• MDR Text Key: 177152568
• Report Number: 3010266064-2019-00128
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other