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

Model Number ROB10013

Device Problems Difficult to Insert (1316); Connection Problem (2900)

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

Event Date 07/06/2021

Event Type  Injury  

Event Description

It was reported that during a set up for a cori assisted tka surgery, bur would not click in real intelligence robotic drill.They could hear the drill unlock, but the bur would not seat in.After multiple attempts tried to enter a case to see what would happen in that situation.Seemed like it took longer than usual for the drill check mark to display on the screen (case (b)(4)).As you press unlock on the screen to insert the bur the system time out error displayed (case (b)(4)).They proceeded to unplugging and replugging drill after quitting case.Changed long attachment and tried rebooting system but after six attempts nothing worked.The procedure was completed, with a delay (less than 30 minutes) by changing to manual procedure.Patient was not harmed as consequence of this problem.Then, they took the system into another room to run diagnostics.They reset the carriage and the issue seem to have resolved, so, they were able to do the entire kpc test and pass and enter a case and pass calibration.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill (us) rob10013, (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A kpc was performed and passed.A case was run and the drill functioned as intended.There were no issues with bur insertion at the connection screen.The handpiece was recognized immediately when plugged in.A log file review was performed, however the drill check mark was displayed in the screenshot.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may have been associated with a loose connection or improper bur assembly.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.Refer to the product instructions for use for guidelines on recovering to a fully manual procedure in the event of an unrecoverable hardware failure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that during a set up for a cori assisted tka surgery, bur would not click in real intelligence robotic drill.They could hear the drill unlock, but the bur would not seat in.After multiple attempts tried to enter a case to see what would happen in that situation.Seemed like it took longer than usual for the drill check mark to display on the screen.As you press unlock on the screen to insert the bur the system time out error displayed.They proceeded to unplug and re-plug drill after quitting case.Changed long attachment and tried rebooting system but after six attempts nothing worked.The procedure was completed, with a delay (less than 30 minutes) by changing to manual procedure.Patient was not harmed as consequence of this problem.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

Manufacturer Narrative

The real intelligence robotic drill (us) rob10013, sn (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A kpc was performed and passed.A case was run and the drill functioned as intended.There were no issues with bur insertion at the connection screen.The handpiece was recognized immediately when plugged in.A log file review was performed, however the drill check mark was displayed in the screenshot.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may be associated with an intermittent failure of the drill exposure motor due to the thermo-mechanical stress induced within the motor at the encoder and electrical noise on the console error status inputs to the drill exposure motor encoder.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior event.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action already implemented.Refer to the product instructions for use for guidelines on recovering to a fully manual procedure in the event of an unrecoverable hardware failure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that during a set up for a cori assisted tka surgery, bur would not click in real intelligence robotic drill.They could hear the drill unlock, but the bur would not seat in.After multiple attempts tried to enter a case to see what would happen in that situation.Seemed like it took longer than usual for the drill check mark to display on the screen.As you press unlock on the screen to insert the bur the system time out error displayed.They proceeded to unplug and re-plug drill after quitting case.Changed long attachment and tried rebooting system but after six attempts nothing worked.The procedure was completed, with a delay (less than 30 minutes) by changing to manual procedure.Patient was not harmed as consequence of this problem.Continuous improvements have been made to the cori robotic drill and manufacturing processes to reduce drill disconnection error messages.These improvements consisted of: 1.A hardware update to the cori console to reduce noise on the internal electronics.2.An update to the cori system¿s software and firmware to improve the user experience when error messages are displayed, and 3.A hardware update to the cori drill to reduce mechanical stress on drill exposure the motor.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL
• 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: 12160486
• MDR Text Key: 261296266
• Report Number: 3010266064-2021-00553
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• 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,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• 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
• Patient Outcome(s): Required Intervention