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

Model Number ROB10013

Device Problem Unintended Movement (3026)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  Injury  

Event Description

It was reported that during a cori tka procedure, when beginning to mill the distal femur, the bur became loose and disconnected from the drill and the robotic drill attachment (despite there being no physical complications during drill setup or error messages notifying that the bur was assembled incorrectly during the setup/calibration stage).It is believed that the bur became disconnected during milling.In order to recover, the robotic drill connection was re-established, setup screen was prompted to ensure proper insertion of the bur, followed by calibration before being able to proceed on to the femur bone removal stage.The delay was less than 30 minutes.Even though there was additional bone removal, no other complications were reported.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6) used in treatment was returned for evaluation.There were no visual observations identified.A functional evaluation found that the drill¿s collet parts were assembled and functioned as expected.The manual bur insertion as well as the software bur insertion function was confirmed to operate as intended.The bur was held with enough force, preventing it from falling out.There were signs the handpiece was spun without the bur inserted (bits of o-ring scattered in the collet).It is likely that the bur was not entirely secured upon bone removal, thus causing the overcut.Although the reported problem was not confirmed through a visual or functional evaluation, a factors that may have contributed to the reported symptom may have been the following: it is possible for the drill to pass calibration with an improperly inserted bur, which is a user error.The bur is secured when the user inserts the bur until a click is heard, as instructed in the bur set up screen.Refer to the real intelligence cori for knee arthroplasty for setting up, unlocking, and loading the bur.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 further 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: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 7634524980
• MDR Report Key: 10709037
• MDR Text Key: 212240224
• Report Number: 3010266064-2020-01910
• 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: 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/11/2022
• 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
• Treatment: ROB10015/RI ROBOTIC DRILL ATTACHMENT; ROB10015/RI ROBOTIC DRILL ATTACHMENT; ROB20000/CORI ROBOTICS USA
• Patient Outcome(s): Required Intervention