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 08/19/2021

Event Type  malfunction  

Event Description

It was reported that, when the surgeon began milling the femur in a cori assisted ukr surgery, he received the system time out notification.They hit continue 3 times and the real intelligence robotic drill would not initialize.They had the surgeon tug on the bur a little to ensure it was seated, hit continue, and it initialized.The surgeon completed milling the femur.Once milling was completed, they noticed a discrepancy in the resection level of the femur.They went back to the femur, verified checkpoints which confirmed nothing moved, they milled over the concerning area again, and it fixed most of the discrepancy.When they train led, the surgeon stated the fit was fine and they proceeded.The procedure was completed without significant delays (5 minutes), using the same devices.The patient was not harmed.

Manufacturer Narrative

The real intelligence cori 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.No apparent discrepancies were identified.The reported complaint could not be confirmed, and it cannot be said that the device contributed to the reported event.It is possible that the user is referring to the green bone along the medial edge of the condyle that remained.It appears that the user was closer to the final cut surface after the first round of refining, although there was still a little bit of green not completely burred away.Although this cannot be confirmed, it is possible that the green left on the bone is due to residual physical bone getting stuck within the drill guard that had slipped down the long attachment, preventing full exposure of the bur to reach the green bone.It is suggested that the drill guard be removed and cleaned off/replaced should it be suspected that the remaining virtual green bone cannot be removed.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.Internal complaint reference number: case-(b)(4).

Event Description

It was reported that, when the surgeon began milling the femur in a cori assisted ukr surgery, he received the system time out notification.They hit continue 3 times and the robotic drill would not initialize.They had the surgeon tug on the bur a little to ensure it was seated, hit continue, and it initialized.The surgeon completed milling the femur.Once milling was completed, they noticed a discrepancy in the resection level of the femur.They went back to the femur, verified checkpoints which confirmed nothing moved, they milled over the concerning area again, and it fixed most of the discrepancy.No undesired cuts were made.When they train led, the surgeon stated the fit was fine and they proceeded.The procedure was completed without significant delays (5 minutes), using the same devices.The patient was not harmed.

• 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: 12456964
• MDR Text Key: 271484692
• Report Number: 3010266064-2021-00639
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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
• Date Manufacturer Received: 04/11/2022
• 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: Unknown
• Patient Sequence Number: 1