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

Catalog Number ROB10024

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

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a cori assisted tka surgery, at the start of the case the cori tibia array was flickering when taking the ankle landmarks, which the surgeon takes with the leg in full extension.As the camera was struggling to get the pointer and array in the field of view, the camera was adjusted to capture the landmarks.The other landmarks and bone mapping continued as usual.When the surgeon came to the planning screen, the tibia was not displayed centered on the screen.At this point, the sales rep, raised concern that the landmarks may not have been taken correctly and that may be the cause of the tibia not being displayed properly on the planning screen.However, the surgeon chose to continue with the software, the femur was cut with the bur distally, then a 4 in 1 cutting block for the remaining cuts.After the femur was cut, the sales rep raised concern again with the tibia model, stating that if the tibia landmarks were incorrect the tibia mechanical axis would also be incorrect.The surgeon chose to continue with the case and the current landmarks.When doing the final gap assessment, the bone model looked incorrect for the tibia.The procedure was performed, without any delay, using manual technique.No further consequences were reported.

Manufacturer Narrative

The real intelligence cori, part number rob10024, serial number (b)(6) , used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.Screenshots and system log files provided were reviewed with the software support team.The reported problem was confirmed.The misalignment is caused by the data out of sync.The issue disappears once the data is fully loaded.This is due to the amount of data loaded during planning.The tibia place off the screen happens when the bone shaft doesn¿t align well with the tibia mechanical axis then the implant drifts off the screen.This could be due to bad malleoli collections or bad free point collections.The most likely cause of this event is a software bug.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicates the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on the investigation, no containment or corrective action is recommended or required at this time.Should any additional information be received, the complaint will be reopened.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: 18927172
• MDR Text Key: 337945433
• Report Number: 3010266064-2024-00060
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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 Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• 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