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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a cori assisted tka surgery, they were prompted to redefine the rotational axis (due to deformity), the m/l axis was malfunctioning.According to the pca number displayed, the femur was rotated 22 degrees from the pca.They tried clearing points and the issue persisted.They collected the rotation based on tea using special points and proceeded to the tibia.They verified the checkpoints and went back to femur rotational axis and the glitch appeared to fix itself.They redefined the axis in the same position and it was now 3 degrees from the pca.They proceeded with the case without further errors.The procedure was completed, with a non-significant delay, using the same device.

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.The femur axis definition was attempted several times, and the 22 degree internal rotation in relation to the pca was confirmed after recollecting the flexion range collection and femur free collection.This became the newly defined femur axis.The subsequent femur axis definition screenshot was internally rotated 3 degrees in relation to the newly defined femur axis.Therefore, the resulting femur axis was internally rotated 25 degrees in relation to the pca.It is possible that unintentional stress was applied to the joint when collecting the flexion range, resulting in the significant rotational angle difference of the defined femur axis to the pca.Further screenshot review found that the pre-operative alignment was 11 degrees valgus.The implant planning screens show significant wear on the lateral condyle and lateral plateau.The severe lateral deformity of the knee is a likely contributing factor to the femur axis rotation.It is also possible that this tka case was a revision surgery of a lateral unicondylar knee arthroplasty (uka) knee.The lateral condyle and lateral tibial plateau appear relatively flat in the implant planning screens, indicating that the (possible) uka components were removed when registering the knee.This would also explain the preoperative 11 degree valgus alignment and the 22 degree femur axis rotation relative to the pca.Cori is not indicated for use in revision surgical procedures.Refer to the indications for use section of the real intelligence cori for knee arthroplasty.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: 12871052
• MDR Text Key: 283174070
• Report Number: 3010266064-2021-00812
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/08/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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