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

Model Number ROB10024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Our reference number: case-(b)(4).

Event Description

It was reported that a patient was scheduled to get a uni knee replacement procedure.The procedure went as planned using the cori robot.However, when the surgeon completed burring the knee and went to do trialing of the implant for the tibia, he compromised the knee so much that the uni procedure was changed to a tka procedure.There may have been an over-resection of the tibia.The surgeon decided to switch from smith and nephew implants to stryker implants and may have had to do some aspect of a revision procedure (there was no issue with s+n implants (they were not available in site due to the change to tka)).No other complication were reported.

Manufacturer Narrative

The real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore a visual and functional inspection could not be performed.A screenshot and log file review was conducted, and the reported problem was not confirmed.The review found that the system operated as intended, and the user cut to plan.Due to the achieved white surface of the tibia, an over-resection of the tibia (other than what was planned for) could not be confirmed.The plan shows that 9 mm of the tibia was to be resected.However, this resection depth could have contributed to the compromise of the knee when trialing the tibia.It is suspected that either the tibia component was not appropriately sized to fit the cortical margin of the bone, or due to the resection depth, the tibia component was placed on the metaphysis section of the bone, which is softer and weaker, making it easier to be compromised.In addition, the gap planning screen shows the patient having an 18 degree flexion contracture.A flexion contracture of this degree is typically a difficult uni surgery to conduct.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.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.It was confirmed that the user cut to plan, and that the system operated as intended.Therefore, an over-resection of the tibia, other than what was planned, could not be confirmed.However, a contributing factor that may have led to the compromise of the knee could be the planned resection depth of the tibia.In addition, conducting a uni surgery on a knee with a flexion contracture of 18 degrees is challenging to execute.This situation is captured in the optimus risk assessment released at the time of the complaint.Based on the investigation, no further containment or corrective action is recommended or required 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
• MDR Report Key: 11335583
• MDR Text Key: 232154653
• Report Number: 3010266064-2021-00116
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention