MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10024

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  Injury  

Event Description

It was reported that a patient with a significant pre-operative varus alignment of 14 degrees underwent into a cori assisted tka surgery.The surgeon chose to adjust both the femur and tibia in 3 degrees of varus, making for a combined 6 degree varus post-operative alignment.For execution, the surgeon did a distal burr bone removal with the cori robot, placed his manual jii cut block, and checked the anterior cut slot for accuracy prior to cutting the femur.Then, used the visualize cut screen to place the manual tibia cut block to match the planned resections to less than a degree deviation from the plan, and cut the tibia with a saw blade.The surgeon did not make any additional soft tissue releases.During trialing, at the post-operative baseline screen, the leg alignment showed 10 degrees of varus, 4 more than what the surgeon had planned for.The post-operative x ray appears that the tibia baseplate is in excessive varus, ~ 7-8 degrees based off of the templating on the x ray.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Manufacturer Narrative

H3, 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.Although the product was not returned the software files were downloaded from the device and provided for investigation.The log files do not indicate any system or software issue related to the reported complaint.The screenshots were reviewed with clinical account representatives.Screenshot review confirmed the pre-operative alignment of 14 degrees varus, as well as executing the planned 6 degree varus post-operative alignment where both the femur and tibia components were set to 3 degrees varus.The 10 degree varus post-operative alignment was also confirmed.The x-ray was also provided for investigation where it is evident that the tibia is sitting in excessive varus.However, the x-ray did not include the hip and ankle, and the alignment of the knee could not be measured to confirm the 7-8 degree varus knee.Discussion with the clinical account representative present during the case provided additional insight to the conduction of the case.The surgeon used the plane visualizer tool to initially navigate the tibia cut block before pinning, and then used the saw blade to make the cut.The surgeon did not go back and use the plane visualizer to verify the cut, nor check the cut with the bur in the bur all mode.The patient had severely hard bone due to their wear patterns, making the sawblade more susceptible to bounce in those areas, likely causing the additional varus to the tibia cut.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• Brand Name: REAL INTELLIGENCE CORI
• 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: 13047259
• MDR Text Key: 283158101
• Report Number: 3010266064-2021-00888
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/22/2022
• 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: A
• Patient Sequence Number: 1