MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI

Model Number ROB10024

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

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

Event Date 05/06/2021

Event Type  malfunction  

Event Description

It was reported that, during a cori-assisted tka surgery, a tibial bone model generation error message was displayed in the real intelligence cori when they went to bur the twin peg holes.The issue was solved when a few points were cleared ((b)(4)).Also, they received a drill disconnect error while using the real intelligence robotic drill to burr the twin peg holes.The drill was reassembled and recalibrated to solve the issue ((b)(4)).The procedure was finished without significant delay (5 minutes).The patient was not harmed.

Manufacturer Narrative

H3, h6.The real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was returned to the designated complaint unit for evaluation, no visual or functional non-conformities were identified.The software files were downloaded from the device and provided for investigation.Screenshots of the case were provided and confirmed the warning message upon entering the tibia bone removal stage: ¿bone model generation error¿.This is a known software issue (bug 1831) that has been corrected and released in cori-v1.4.3 software.Refer to the real intelligence cori for knee arthroplasty user manual for data point collection, including tibia free collection.If a collection error occurs, a message displays, reporting the specific error to the user, and providing instruction for solution.Most indications require clearing the message from the screen, by pressing ok, and performing the steps again to re-collect.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.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.This issue will be continuously monitored through complaint investigation and post market surveillance.

• 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
• 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: 11872865
• MDR Text Key: 252363096
• Report Number: 3010266064-2021-00405
• 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: K201022
• 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: 08/05/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/05/2022
• 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