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

Catalog Number NPFS02000

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problems Injury (2348); Deformity/ Disfigurement (2360)

Event Date 09/23/2020

Event Type  Injury  

Event Description

It was reported that, during a navio-assisted ukr procedure, the lug holes were not completed as some blue areas remained, resulting an incomplete seating of the component and, therefore, pushing into slight valgus.It caused incorrect final alignment.The problem was resolved by removing more tibia.Surgery was not delayed beyond 30 min.

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 and reviewed.It was confirmed that the lug holes had 1 mm (green) of bone left to be resected.The final planned alignment of 1 degree varus, and the post-operative alignment of 1 degree valgus was also confirmed.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 evaluation concluded that, based on the documentation provided, the surgical technique could not be ruled out as a contributing factor to the reported events.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.Further review of the screenshots addressed the additional comments of the reported description: the pre-op neutral position (taken around 5 degrees of flexion) was in 2 degrees varus.The initial planning screens show the post-operative alignment as 0 degrees valgus.However, the user had adjusted the plan multiple times.The final planning screen shows the planned alignment to be in 1 degree varus.The final postop baseline screen shows the patient in 1 degree valgus, taken at 3 degrees of flexion.The pre and post-op alignments were taken around the same flexion position of the knee, therefore this is a compatible and realistic comparison of the pre and post-op leg alignments.The femur bone removal screen shows green in the lug holes, indicating a millimeter of bone was not resected.Because this lack of resection would prevent the femur from being completely seated, the overall knee alignment would be more valgus than what was planned.The femur cut screen also shows some high spots that had not been resected, which also may have contributed to the post-op valgus alignment.It could not be confirmed whether the tidemark point was sub-optimal.Regardless, this collection does not affect the knee alignment.This point is where distal femoral resection should begin, because it is the most anterior point of wear.This point is used for femur component placement and sizing, not leg alignment.The patient shows 130 degrees of flexion.Unless a patient is able to reach around 140 degrees or more of flexion, the lug holes are difficult to bur should there be significant femoral component flexion.Femoral component flexion in implant planning is the angle of the implant's fixation peg relative to the femoral mechanical axis.Flexion of the femoral component began at 45 degrees, which is the recommended angle determined by the manufacturer.The component was flexed out to 50 degrees, meaning the implant was tipped anteriorly where the implant's fixation peg was 50 degrees to the femoral mechanical axis.It is possible that this could be a contributing factor to the incomplete burring of the lug holes.However, the reported event description does not include difficulty in burring the lug holes.The minimal bone removed in the early, mid-range of the femoral compnent is to be expected because the distal end of the condyle was worn out.Therefore, not much bone was going to be resected.The alignment (valgus) and rotation (external) of the femoral component does not affect the overall alignment of the knee.The neutral position and the pre-op non stressed collection rom were viewed in casevisualizer.It does not appear that varus stress was applied during neutral position.If this had been the case, it would be a contributing factor to mismatching pre-op and post-op alignments.The neutral position was collected with less flexion than the non stressed collection rom, however, this is expected because the range of flexion is collected from 20 to 120 degrees, and the low flexion angles are excluded.The tibia rotation is fine because the implant placement is along the point probe, representing the intercondylar eminence ridge.The most likely cause of the post-operative valgus leg alignment is a combination of the incomplete femur lug holes drilled and the high spots of the femur (as found in the femur cut screen).The navio user¿s manual provides instructions on cutting the post (lug) holes.The navio¿ surgical system displays color coding to identify bone regions and indicate the amount of bone to be removed.During the bone removal stage, white indicates that the target surface has been reached.Bone to be removed will change colors based on its thickness.If bone is cut deeper than called for by the plan, the system highlights this region in red.As bone is removed, the onscreen model indicates the depth of the cut.The goal is to cut through the colored layers of bone until the white target surface is revealed.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.

Event Description

It was reported that during navio ukr procedure while patient under anesthesia lug holes not completed as some blue remains resulting an incomplete seating of the component, therefore pushing into slight valgus.It caused incorrect final alignment and was recover removing more tibia.Delay less than 30 minutes reported.

• 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: 10690957
• MDR Text Key: 211696016
• Report Number: 3010266064-2020-01878
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention