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

Model Number ROB10024

Device Problems Application Program Problem: Parameter Calculation Error (1449); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, they experienced a ¿mismatch¿ regarding the rom number provided on the planning screen vs the number shown on the gap assessment screen.Once on the planning screen, the flexion range showed 8°-140°.On the following gap assessment screen, the value showed 2 degrees of flexion.They restarted the entire case by exiting, creating a new case, and completely re-registering.They ensured the leg was in full extension during the neutral position collection, while applying slight axial load, as well as ensuring full extension was captured on the un-stressed rom screen.The numbers did not change.They backed out of the case to attempt to re-register a third time and again, the numbers did not change.Once on the planning screen, before implants were manipulated in any manner, he noticed that there was 1 degree of varus placed on the tibia and 1 degree of varus placed on the femur.They confirmed that once this new case was entered, no adjustments were made to the components.Once they entered the gap assessment screen, holding the leg in full extension again showed that the preoperative rom was at 2 degrees.The surgeon was unsure how to plan for his distal resection, as he would obviously plan to resect more bone for a larger contracture.Ultimately this case was successful.The procedure was completed with the same device without significant delays.The patient was not harmed beyond the reported problem.Additionally, they attempted to pull log files multiple times with various 3.0 or higher usbs.The export button was grayed out while using one usb.The export showed an error while using another usb.Another attempt resulted in the system freezing, which required a hard power down.

Manufacturer Narrative

H3, h6.The real intelligence cori, pn rob10024, (b)(6).Used for treatment was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.From the pictures provided, we confirmed that the implant planning screen showed a flexion range of 8-140 degrees.Half of the gap assessment screen was also provided, which shows the live readout of the knee at 2 degrees of flexion.The flexion range obtained during registration is what is displayed on the implant planning screen.This range is separate from the range of motion collected for the gap assessment.It appears that the neutral position was also collected around 2 or 3-degrees flexion.The neutral position (displayed as a blue n with a hashmark line), is also separate from the flexion range collection.Therefore, the 8 degrees in the beginning of the flexion range will not necessarily be the same as the neutral position degree.Because the log files were not provided, we cannot confirm that the case had been exited and reentered with the reported same values presented.No reasonable cause could be identified based on the received complaint information and investigation results.A review of manufacturing records indicates the software met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.Prior escalation actions are not applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• 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: 14545167
• MDR Text Key: 292957607
• Report Number: 3010266064-2022-00419
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

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: 05/10/2022
• Initial Date FDA Received: 05/30/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 11/30/2022
• 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