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

Model Number ROB10013

Device Problem Mechanics Altered (2984)

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

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, during distal bur in exposure mode in a cori assisted tka surgery, the surgeon was not able to get the green off the screen.Even after a saw and rasp was used to take a sliver of bone off surgeon still couldn¿t take green off.When they switched to speed mode it would take off the green.No additional/unplanned bone cuts were made.The procedure was completed with the same device without significant delays.The patient was not harmed beyond the reported problem.In addition, the real intelligence robotic drill used in this case returned for evaluation and it was found that the exposure motor was loose.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6) used in treatment was returned for evaluation.The software files were downloaded from the device and provided for investigation as well.Case id: (b)(4) was evaluated for the occurrence date of (b)(6) 2021.There were no auto or user-taken screenshots in the femur bone removal screen with the resulting green bone.However, a photo of the femur cut screenshot with green bone remaining was provided, confirming the reported complaint.Visual and functional evaluations were done on the drill.There were no visual abnormalities, however, the drill failed multiple functional evaluations including the max homing torque and the homing range value of the robotic drill diagnostics kpc tests.The drill was also taken through the handpiece calibration verification stage of a case multiple times to see if the bur positioning would pass, where it failed three out of four times.The drill¿s motor cover was removed, confirming the exposure motor had unthreaded.This likely prevented full exposure of the bur, resulting in the inability to burr the remaining green bone.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.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 ; 5123913905
• MDR Report Key: 13896534
• MDR Text Key: 288168014
• Report Number: 3010266064-2022-00212
• 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
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• 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: Unknown
• Patient Sequence Number: 1