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 Code Available (3191)

Event Date 08/31/2020

Event Type  Injury  

Event Description

It was reported that during a cori tka procedure, the surgeon felt that the bur was not burring efficiently and that it kept retracting back into the guard when he tried to push down to bone surface.They tried cutting in exposure mode on distal femur and on the tibia both perpendicular to cut and parallel, but he could not get to point he felt it was cutting.The procedure was changed to manual instruments, he navigated the blocks for both femur and tibia and cut with saw.There was a delay of less than 30 minutes.No other complications were reported.

Manufacturer Narrative

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 and the reported problem could not be confirmed.Screenshots and log file review could not confirm whether the bur was burring efficiently or retracting prematurely when pushing the bur down to the bone surface.The case was put in case visualizer, where it was verified that the checkpoints were in positions that would not have been disturbed during bone removal.This indicates that tracker movement potentially causing an under-resection of the bone was unlikely.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 is warranted at this time.Should additional clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.Although the reported problem was not confirmed, a contributing factor for premature bur retraction and inefficient burring could be a possible hardware issue with the bur, or a 6 mm bur was used when a 5 mm bur was selected.However the hardware was not returned at this point in time for evaluation.Refer to the cori user¿s manual for bur selection recommendation.Another contributing factor could be related to the ¿remove magenta¿ selection early on in the femur bone removal screens.It is possible that where the purple bone was virtually removed, the physical bone may have still been present.Less efficient burring in the physical purple area of the bone may have been a result of this.Per the cori user¿s manual: ¿as bone is removed, the onscreen model indicates the depth of the cut.The goal is to cut through the colored layers of bone until the white target surface is revealed.¿ this situation is captured in the optimus risk assessment released at the time of the complaint.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
• MDR Report Key: 10582836
• MDR Text Key: 208415427
• Report Number: 3010266064-2020-01795
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention