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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Event Description

It was reported that when entering planning during a cori ukr procedure, it was noticed the femur was off significantly in initial placement.When they moved the implant to a correct position the gaps were very off.They went back to paint more and then simply matched the models and did not rely on the gaps.They were able to move to cutting and checkpoints were confirmed.All resections looked accurate but final alignment showed ~14 varus but this did not reflect what surgeon saw which was a straight, well aligned and balanced uni.There was a delay of less than 30 minutes.No other complications were reported.

Manufacturer Narrative

H10: internal complaint reference (b)(4).Section: h3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.The product was not returned however the software files were downloaded from the device and provided for investigation.Screenshot review confirmed the initial implant placement shows large gaps, but a reasonable implant initial placement.However, the femur¿s tracking points on the tibia in the component m-l position adjustment screen indicates the tibia is translated medially compared to the femur.It is possible that the articulating surface of the medial condyle was very close to the intercondylar eminence ridge of the tibia when taking the neutral position and the rom.Although there were no checkpoint verification errors, tracker movement cannot be ruled out if the checkpoints were taken on the bone trackers or the clamps.It was confirmed that the preoperative gaps exceeded 5 mm in the initial placement of the implants.It should be noted that there is significant posterior slope native to the knee of the tibia in comparison to the 5 degree slope of the tibia component, and the preoperative knee alignment is 9 degrees varus.These factors could contribute to a large preoperative gap.Therefore, it is possible that the gap is real/correct.No preoperative, long-standing x-rays were provided to confirm the 9 degree preoperative leg alignment.Further screenshot review found significant tibia bone refinement of the the colored bone layers as well as the target surface (white bone), indicating there was no bone in the refined area.This also would have contributed to the large preoperative gaps.Because the virtual tibia bone did not match the physical bone, tracker movement of the tibia could be a contributing factor, or if osteophytes existed and were included in the free point collection but removed prior to burring.It was confirmed that the knee's post-operative alignment was 14 degrees varus at 11 degrees of flexion.Again, tracker movement could be a possible contributing factor to the varus knee compared to the user's "straight, well-aligned and balanced uni." however, no post-operative long-standing x-rays were provided to confirm a straight post-operative leg alignment.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.As a result of these findings, it was determined that the software functioned as intended; no defect of the system occurred.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: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 7634524980
• MDR Report Key: 10717905
• MDR Text Key: 212492222
• Report Number: 3010266064-2020-01931
• 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: K191223
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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: 11/23/2021
• 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