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

Catalog Number NPFS02000

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

Patient Problem Injury (2348)

Event Date 06/02/2020

Event Type  Injury  

Event Description

It was reported that during a tka procedure (legion ps implant), after burring the distal femur, the lugs were prepared with the 5 mm cylindrical bur.The 45 mm femur punch was used to prepare the pilot holes for the 4-in-1 block.After placing the 4-in-1 block, the anterior slot was checked with the plane checker and found that it was 2 mm anterior to the plan.Troubleshooting: 1) passed checkpoint verification; 2) surgeon didn¿t use checkpoints, instead used the divots in the back of the clamps (he did not believe they slid down because he secured them tightly; 3) there was no wobble with the 4-in-1 cut block; 4) there was no wobble within the lug holes with the punch.He posteriorized the holes by 2 mm manually with the block that says "anterior" (using it upside-down) and when still anterior to the plan by about 2 mm, the femur was downsized from 5 to 4.Later, it was noticed that the handpiece array had become loose, and proceeded to hand-tighten it.It was not recalibrated, and the surgeon preferred to continue with post-op gaps.The surgeon was pleased with the outcome.He stated that with an accurate distal cut from navio, he was able to perform the rest of the cuts manually on the femur.There was a delay of less than 30 minutes.There were no issues with the tibia.

Manufacturer Narrative

H3, h6: the navio surgical system us, pn: npfs02000, sn: (b)(6) used in treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.The case files were provided for review, and the reported problem could not be confirmed.The visualize cut screenshots of the femur bone removal stage did not capture the use of the plane visualization tool showing the live read-out to confirm the anterior slot was 2 mm anterior to the plan.Following the distal cut of femur bone removal, screenshots show the checkpoints were taken and passed.The case was put in casevisualizer, where it was confirmed that the checkpoints were not taken on the bones.They appear to be on the clamps of the bone trackers.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.The clinical/medical evaluation found that there was no patient injury/impact as the procedure was completed with cuts manually on the femur.There was a delay of less than 30 minutes.There were no issues with the tibia.No further medical assessment is warranted at this time.Although the reported problem was not confirmed, it is possible that the 4-in-1 block had virtually shifted 2 mm anterior due to moved checkpoints.This tracker movement would have gone undetected because the checkpoints were likely taken on the clamps.If the clamp is loose, both the clamp and the bone tracker would move together down the bone pins.This would not alert the system of a checkpoint error, because the checkpoint is still the same distance from the flat markers on the bone tracker.As reported, after distal cut, the user then posteriorized the holes by 2 mm manually and the system still showed the block anterior to the plan by about 2 mm.It was not until after this that it was noticed that the handpiece array had become loose.If the clamps did not move and the distal cut was executed as planned, it is also possible that the femur bone tracker had loosened over time, causing the shift of the holes for the anterior cut.Detailed instructions for placing the bone pins and tracker arrays is provided in the surgical technique guide.Checkpoint pins should be placed in both the femur and the tibia, in positions where they will not be disturbed during bone removal.The recommended position for the femoral checkpoint pin is in the medial or lateral femoral metaphysis.The recommended position for the tibial checkpoint pin is within the incision distal to the anticipated tibia cut.Refer to the user¿s manual for the placement of the bone tracker attachments.Rigid fixation of the femur and tibia tracking arrays into the bone is critical for a successful navio surgical system surgery.If it is suspected that a bone tracker array has moved during surgery, secure the tracker array and click on the appropriate icon to return to the checkpoint verification screen to re-collect and reverify the checkpoints.This situation was captured in the navio risk assessment released at the time of the complaint.As a result of these findings, it was determined that the software functioned as intended; no defect of the system occurred.Based on the investigation, no containment or corrective actions are recommended at this time.

• 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: 10204677
• MDR Text Key: 196744908
• Report Number: 3010266064-2020-01623
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2020
• 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?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention