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

Model Number ROB10017

Device Problems Application Program Problem: Parameter Calculation Error (1449); Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  Injury  

Event Description

It was reported that during cori tka procedure while patient under anesthesia, after completing the distal cut, surgeon used probe to navigate position of femoral lugs, marking the center point with a marking pen, drilling the hole, and then verifying placement with the probe on both lugs.Placement was centered on both.Surgeon then attempted to place correct side, model, and size of cutting block and complained that the tines did not align to the drilled holes.It was confirmed that the correct cutting block was selected and re-verified the position of the lug holes.Surgeon said the cutting block tines were 2-3mm narrower than the drilled holes.Surgeon drilled new lug holes in a plane parallel to the original lugs.Delay reported less than 30 minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.A visual inspection and functional evaluation were done on the console.There were no visual or functional non-conformances related to the reported event identified.The point probe and the cutting block were not returned for evaluation, and the case/log files were not provided for review.Therefore, the reported discrepancy could not be confirmed.As described in the complaint, the user had marked the femur lug holes with a pen and verified those marks with the point probe, then drilled the femur lug holes.The user then attempted to place the cutting block tines in the femur lug holes.The tines of the distal punch and the distal cut guide will align.Once the cuts are made and the femur trial is selected, the implant is placed on the bone and the posts are drilled through the lug holes of the implant.These lugs holes are not aligned with the holes created by the tines of the distal punch guide and cut block.This is the likely cause of the reported 2-3 mm discrepancy between the cutting block tines and the drilled femur lug holes.For guidance on using the distal femur punch and distal cut guide, refer to the ¿performing distal precision burring¿ and ¿using the robotics distal cut guide¿ sections of the real intelligence cori for knee arthroplasty user manual ((b)(4)).The clinical/medical evaluation concluded: ¿based on the information provided, the root cause of the reported event could not be definitively concluded.The patient impact beyond the reported change in surgical technique with additional parallel femoral lug holes and surgical delay could not be determined as the patient status was not provided.No further medical assessment is warranted at this time.¿ 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.

Event Description

It was reported that, after completing the distal cut during a cori assisted tka surgery, surgeon used the real intelligence point probe to navigate position of femoral lugs.He marked the center point with a marking pen, drilled the hole, and then verified placement with the probe on both lugs.Placement was centered on both.Then, surgeon attempted to place correct side, model, and size of cutting block and complained that the tines did not align to the drilled holes.So, they confirmed that the correct cutting block was selected and re-verified the position of the lug holes; however, surgeon said the cutting block tines were 2-3mm narrower than the drilled holes.The procedure was completed, with a non-significant delay, by drilling new lug holes in a plane parallel to the original lugs.Patient was not harmed beyond this incident.No further complications were reported.

• 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; suite 100; austin, TX 78735 ; 5123913905
• MDR Report Key: 10813327
• MDR Text Key: 215472769
• Report Number: 3010266064-2020-01971
• 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,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10017
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ROB20000/CORI ROBOTICS USA
• Patient Outcome(s): Required Intervention