MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI

Model Number ROB10024

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

Patient Problems Physical Asymmetry (4573); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  Injury  

Event Description

It was reported that during a cori assisted tka surgery, the real intelligence cori was showing the posterior slope value about 9° more posterior than the planned slope of 3° (the doctor had accurately collected ankle and tibia knee centers).He had efficiently milled down to the white, and properly placed the visualization tool on the bone.There was additional bone cut (more posterior slope).They checked and confirmed the arrays hadn't moved.He was concerned about the accuracy of the cut, and had to finish the proximal tibia cut without confirmation of an accurate cut.After the case, they checked the visualization tool thoroughly to see if it was bent, and found it to be in good condition.The procedure was completed, with a minimal delay (fewer than 30 minutes) using the same device.No other complications were reported.

Manufacturer Narrative

G3, h2, h3 and h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for 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.Screenshots confirmed that the plane visualization tool¿s live read-outs of the tibia cut were recorded twice.They were 9.8 degrees and 8.9 degrees different from planned, respectively.It was also confirmed that the tibia bone removal screen does not show the entire tibia resected to the white target surface prior to using the plane visualization tool.This could produce an error when using the plane visualization tool.Further analysis of the tibia bone removal screen shows about 1/3 of the tibia was milled to the white target surface, and that the plate probe evaluated the cut angle of this surface.However, there is an anterior, lateral portion near this white surface that is purple.Where the user may have thought the plane visualization tool was resting flat on the white surface, it may have also been resting on that small anterior portion, causing the angles on the live read-out screen.The checkpoints were verified to be on the bone in casevisualizer.Therefore, if there had been tracker movement, the system would have alerted the user.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 concluded that, based on the product evaluation, the use of the visualization tool with inadequate seating on incompletely resected tibial bone could not be ruled out as potential contributing factors to the reported events.The provided lateral x-ray appears to show a posteriorly positioned tibial baseplate which supports the complaint.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.The most likely cause of the tibial slope difference between the planned and the live read-out using the plane visualizer could be the lack of total tibia resection prior to using the plane visualization tool.Refer to the real intelligence cori for knee arthroplasty user manual (500230) during the bone removal stage.Bone to be removed changes colors based on its thickness.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.How to use the plane visualization tool can also be found in the real intelligence cori for knee arthroplasty user manual.This tool can be used after bone removal to visualize the actual cut prepared.This situation is captured in the optimus 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.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

G3, h2,h3 and h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for 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.Screenshots confirmed that the plane visualization tool¿s live read-outs of the tibia cut were recorded twice.They were 9.8 degrees and 8.9 degrees different from planned, respectively.It was also confirmed that the tibia bone removal screen does not show the entire tibia resected to the white target surface prior to using the plane visualization tool.This could produce an error when using the plane visualization tool.Further analysis of the tibia bone removal screen shows about 1/3 of the tibia was milled to the white target surface, and that the plate probe evaluated the cut angle of this surface.However, there is an anterior, lateral portion near this white surface that is purple.Where the user may have thought the plane visualization tool was resting flat on the white surface, it may have also been resting on that small anterior portion, causing the angles on the live read-out screen.The checkpoints were verified to be on the bone in casevisualizer.Therefore, if there had been tracker movement, the system would have alerted the user.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 concluded that, based on the product evaluation, the use of the visualization tool with inadequate seating on incompletely resected tibial bone could not be ruled out as potential contributing factors to the reported events.The provided lateral x-ray appears to show a posteriorly positioned tibial baseplate which supports the complaint.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.The most likely cause of the tibial slope difference between the planned and the live read-out using the plane visualizer could be the lack of total tibia resection prior to using the plane visualization tool.Refer to the real intelligence cori for knee arthroplasty user manual (500230) during the bone removal stage.Bone to be removed changes colors based on its thickness.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.How to use the plane visualization tool can also be found in the real intelligence cori for knee arthroplasty user manual.This tool can be used after bone removal to visualize the actual cut prepared.This situation is captured in the optimus 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.No containment or corrective actions are recommended at this time.

• Brand Name: REAL INTELLIGENCE CORI
• Type of Device: REAL INTELLIGENCE CORI
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11921148
• MDR Text Key: 253758163
• Report Number: 3010266064-2021-00431
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

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 Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 09/10/2021
• Supplement Dates FDA Received: 08/10/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REAL INTELLIGENCE 5 MM CYLINDRICAL BUR/ 50926755; REAL INTELLIGENCE PLANE VISUALIZER/ (B)(6)
• Patient Outcome(s): Required Intervention