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

Catalog Number NPFS02000

Device Problems Device Difficult to Program or Calibrate (1496); Calibration Problem (2890)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  Injury  

Event Description

It was reported that after planning the knee for a navio procedure, they progressed to the cut screen and navio prompted them to check the checkpoints to make sure nothing moved and they could progress to bone preparation.The femur checkpoint registered and was in the same place.When they checked the tibia it showed an 8mm movement error.They were using checkpoints and the surgeon was certain that the tracker array had not moved.They redefined the point and moved forward.They burred the distal femur and the surgeon thought that the placement of the femoral component looked off center, so he moved it over using visionair.When they progressed to the tibia cut screen, they switched to refine mode and had him use the bur to make sure they were in the right place.He moved the bur to the furthest medial side of the tibia and it showed he was way off the bone.At that point he decided to use visionair to cut the tibia and finish the case with a delay of fewer than 30 minutes.When they exited the case, they got a warning screen that showed "navio has detected problems with the with the tracking system".

Manufacturer Narrative

H3, h6: the navio surgical system (us), product npfs02000, (b)(6) used for treatment was not returned for evaluation, however log files were provided in the field report for review.A screenshot during the case states "navio has detected problems with the tracking system.Full navio functionality will remain unavailable until this issue is resolved".A relationship between the reported event and the device was confirmed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is tracker array movement or failure.The navio surgical technique manual ((b)(4)) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines" section of "performing trial reduction and postoperative assessments".This failure is an identified failure mode within the risk assessment.Per the field report, a tracking system error/warning showed as the case was exited.Per complaint details, this resulted in an 8mm tibial movement error which prompted the surgeon to abandon the navio¿ and complete the procedure manually with visionaire¿, with a 0-30 minute surgical delay.Reponses to the information requests were not provided.Based on the information provided, the impact beyond the reported modified manual procedure using visionaire¿ and the surgical delay could not be determined.No further medical assessment is warranted at this time.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10875614
• MDR Text Key: 217344015
• Report Number: 3010266064-2020-02021
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention