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

Model Number ROB10024

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

It was reported that, during a cori tka procedure, when unplugging the drill from the console, the screen went black and gave an "internal error" on the case information screen.They dismissed the error and pressed resume operation.This then took them through the calibration phase and then it took us to the "planning screen".Since the problem could not be solved, they switched the drill for its backup to move forward with the case.There was a delay of fewer than 30 minutes.No other complications were reported.

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.The case files were downloaded from the device and provided for investigation.The naviosystem.Logs were reviewed and confirmed the reported "internal error" message.This error occurred after a "robotic drill cable disconnected" error that had occurred during the bone removal stage.An "internal error" message may be displayed to the user shortly after a "robotic drill cable disconnected" error.The user sees an "internal error" message on the screen, but the screenshot itself is not saved.This internal error is a result of an intraop crash due to either of the following: 1.The user leaves the bone removal state and tries to reenter handpiece connection by clicking "continue" in the robotic drill cable disconnected error dialogue box when the handpiece is still in a disconnected state.Conducted by software engineering, debugging of this error found that a pfs workpiece is deleted in the intraop when exiting bone removal after a handpiece disconnection.In attempts to update the workpiece with the drill disconnect error information, the intraop crashes because the workpiece was deleted and no longer works.2.The transition from disconnected to connected state of the handpiece is too slow and is not yet considered to be "identified" by the tcu, but the tool parameters of the handpiece are being queried.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 part of corrective actions, this issue has been corrected and released in cori-v1.4.3 software.

• 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: 10875886
• MDR Text Key: 217424451
• Report Number: 3010266064-2020-02026
• 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

• 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: 11/04/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: No
• 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