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

Model Number ROB10013

Device Problems Overheating of Device (1437); Connection Problem (2900); Physical Resistance/Sticking (4012)

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

Event Date 04/25/2021

Event Type  malfunction  

Event Description

It was reported that, during a training session with cori system, a multitude of errors were experienced: drill disconnect errors, which appeared to be due to overuse or overheating and the bur became stuck inside the drill and attachment could not be removed to remove the handpiece tracker; a back slap was used to disengage the bur and the pieces were removed and used on the other handpiece ((b)(4)); the other drill stopped working and the system had to be restarted entirely ((b)(4)).Also, there was a tibial bone model generation error, which was bypassed by removing a few points before continuing; a critical error notification; and a bad console notification; while entering a new case, the system shut down and the blue man appeared so a reboot was required ((b)(4)).As this event happened during a demo, no patient was involved.

Manufacturer Narrative

H3, h6: the cori drill p/n rob10013 (b)(6) intended for use in treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.A kpc was performed and passed.The reported problem was not confirmed.The drill was not hot to the touch at any time during testing.The bur does not get stuck in the drill.The drill functions as intended without any connection issues or errors.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.Although the reported problem was not confirmed, no reasonable contributing factors could be identified based on the received complaint information and investigation results.Based on the investigation, no further containment or corrective action is recommended or required at this time.

Manufacturer Narrative

The cori drill p/n rob10013, sn (b)(6), intended for use in treatment was returned.A functional evaluation was performed and the reported errors were not confirmed.The drill functions as intended without any connection issues or errors.Although the drill operated as intended, the log files were provided for review and confirmed the reported drill disconnect error messages for drill sn000368 in the bur loading stage.These error messages were triggered by a tool homing failure error.A tool homing failure error could be due to a possible obstruction in the drill that prevented the drill from homing properly, or an intermittent issue with the exposure motor.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 device met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.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 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
• MDR Report Key: 11814230
• MDR Text Key: 250525138
• Report Number: 3010266064-2021-00367
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/07/2023

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: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 06/09/2021; 01/30/2023; 02/05/2023
• Supplement Dates FDA Received: 06/15/2021; 02/01/2023; 02/07/2023
• 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: A
• Patient Sequence Number: 1