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 06/23/2021

Event Type  Injury  

Event Description

It was reported that, upon attempting to collect neutral position in a cori-assisted tka surgery, an error message saying "the malleoli points were collected in the wrong order.Press ok to collect again" was displayed.They attempted to collect the malleoli points 2 additional times.During all three collections they were certain that the medial side was collected first.They were then able to perform knee centers, hip center, and all three times during neutral position collection, they received the above error.Since they could not clear the error, the procedure was completed with manual instrumentation without significant delays.The patient was not harmed.Additionally, all three times the medial side was collected first, all three times the knee center collections were on the correct bone and in accurate positions, and the tracker arrays were correctly placed on the tibia and femur.It may be worth noting that the surgeon always stands on the patients right side, however he was operating on the left knee.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used in treatment was returned to the designated complaint unit for evaluation.No visual or functional non-conformances were identified.The software files were provided for investigation.Screenshot review confirmed the reported collection error stating the malleoli points were collected in the wrong order after three neutral position collections.This error was recreated when the hardware and specific point registration was conducted as follows: the femoral tracker was pointed toward the ceiling as much as the camera¿s visibility would allow, which was drastically pointed in the positive y-direction.These coordinates create the ¿left vector,¿ which are the coordinates of the femoral tracker in relation to the camera.The ¿lm vector¿ is the second vector that is created between the lateral malleoli to the medial malleoli coordinates.A very low point of the medial malleoli was collected, and a very high point of the lateral malleoli was collected.The lm vector then pointed drastically in the opposite direction of the left vector.When the left vector (femoral tracker) points drastically in the positive y-direction (toward the ceiling), and the lm vector drastically points in the negative y-direction (toward the floor), the occurrence of this error is high.This error happens during neutral position collection because this is where the left vector is obtained.As determined by the software, the resulting angle of these vectors (vectors pointing in the opposite direction of each other) had made the malleoli appear out of order.The software functioned as required, and the error was presented under the correct conditions.The log files were reviewed and confirmed that the angle between the two vectors resulted in a value that would prompt the "the malleoli points were collected in the wrong order¿ error message.The most likely cause of this error would be a low medial malleoli point collection (closer to the foot) and a higher lateral malleoli point collection (above the ankle bone) and/or the femoral tracker pointing toward the ceiling during neutral position collection.Refer to the users manual for collecting the malleoli points.Place the tip of the point probe on the highest prominence of both the medial and lateral malleoli.The real intelligence cori for knee arthroplasty user manual (500230) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".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: 12125459
• MDR Text Key: 261478262
• Report Number: 3010266064-2021-00521
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/23/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/14/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention