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

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 11/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after a cori assisted tka surgery, the knee's leg alignment read 3 degrees valgus and was clinically, visibly in valgus to the surgeon's eye.There was no valgus planned into the cuts during planning.Both tibia and femur bone removal were done in burr all mode.Checkpoints were used.No tracker movement throughout the case.The surgeon is dissatisfied with these results, and due to the valgus appearance of the tibia cut during trailing, surgeon went back to the plan and changed it to a 2 degree varus alignment.However, he did not execute this.The final tibia cut stayed at zero degrees neutral.The procedure was completed after a non-significant delay.Patient outcome is unknown.

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.The product was not returned however 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 the clinical account representative, and the reported problem was confirmed.The implant planning screens show a pre-operative and post-operative leg alignment of 0 degrees valgus.After the initial femur and tibia cuts, the user went back to the implant planning stage and changed the post-operative leg alignment to 2 degrees varus.The screenshots do not show the surgeon having cut to this updated plan.The clinical account representative discussed this issue with the surgeon after the case.When registering the alignment of the knee in the neutral position collection and flexion range collection, it is possible that, instead of a natural extension of the knee, there was unintended stress applied to the knee that may have skewed the preoperative leg alignment.It is also possible that the surgeon had nicked the mcl during bone removal, making the mcl more lax and resulting in a post-operative valgus alignment.Refer to the real intelligence cori for knee arthroplasty user manual when properly collecting the preoperative mechanical alignment.Neutral position registration is used to determine the preoperative varus/valgus alignment of the knee joint in the patient¿s natural extension, with no varus or valgus stress applied.Place the patient¿s leg in a neutral position (the patient¿s native extension), applying slight axial pressure through the ankle to both compartments.It is very important not to move the joint during neutral position data collection; doing so potentially may skew data analysis later in the procedure.According to the ¿performing total knee arthroplasty (tka): removing bone during tka¿ section of the real intelligence cori for knee arthroplasty user manual, use retractors to protect soft tissue and ligaments from damage due to inadvertent movement of the robotic drill and bur.The clinical/medical evaluation concluded: ¿based on the information provided, the clinical root cause of the reported unplanned valgus outcome could not be definitively concluded.The engineering evaluation, however, noted that errors during pre-op leg alignment registering or an intra-op mcl injury could result in a similar outcome.The user technique also could not be ruled out as a contributing factor to the reported valgus outcome as the changed plan (to a 2-degree varus alignment) was not executed and the procedure was completed with the same device/not manual instrumentation.Patient impact beyond the reported unplanned valgus outcome and a 0-30 minute surgical delay could not be further assessed and an increased risk of early intervention and/or revision could not be ruled out.No further medical assessment can be rendered at this time.¿ 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.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This situation is captured in the risk assessment released at the time of the complaint.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: 12844502
• MDR Text Key: 281018412
• Report Number: 3010266064-2021-00787
• 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: 01/25/2022

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: 11/02/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 01/25/2022
• 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: Unknown
• Patient Sequence Number: 1