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

Model Number ROB10024

Device Problems Application Program Problem: Parameter Calculation Error (1449); Unintended Application Program Shut Down (4032)

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

Event Date 06/09/2021

Event Type  malfunction  

Event Description

It was reported that, during tibial bone removal in a cori-assisted tka surgery, a tibial bone model generation area message was displayed.Three of four points were cleared and continued was pressed and the error was displayed again ((b)(4)).Three of four points were removed per second time and the bone model was generated.Additionally, when the surgeon stepped on the pedal to spin the burr, a drill disconnect error message was displayed ((b)(4)).The case was quit, and an internal error message was displayed ((b)(4)).The case was resumed, the real intelligence drill was assembled, calibrated, and a second drill disconnect and internal error messages were displayed.The real intelligence cori was rebooted, the drill was unplugged and disassembled, then it was plugged in and it was noticed that the light was blinking over the drill plug in.Unlock was pressed and immediately received a drill disconnect.The case was quit, and the procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.

Manufacturer Narrative

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.Although the product was not returned the software files were downloaded from the device and provided for investigation.Screenshots of the case were provided and confirmed the two warning messages upon entering the tibia bone removal stage: ¿bone model generation error.¿ as part of corrective actions, the tibia bone model generation error has been corrected and released in cori-v1.4.3 software.The internal errors occurring after the drill disconnect error were also confirmed via log file review.The drill was not returned for investigation.However, having reviewed the log files, the most likely cause of these reported errors are related to the drill temperature sensor.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.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.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: 12050186
• MDR Text Key: 259597986
• Report Number: 3010266064-2021-00482
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/16/2022
• 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