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

Model Number ROB10013

Device Problem Unstable (1667)

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

Event Date 06/25/2021

Event Type  Injury  

Event Description

It was reported that during a cori assisted ukr surgery the surgeon completed all of the femur burring excerpt posteriorly and moved on to bur the tibia.He returned to finish the femur after completing the tibia and alerted of a bony defect on the femur.It is suspected that the bur kicked up into the femur while burring the tibia; however, it was thought there was a robotic safety mode.The procedure was completed without delay.Perfect outcome per surgeon.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.The drill functioned as expected without any connection issues or errors.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is improper method of burring the tibia implant region.Refer to the real intelligence cori for knee arthroplasty user manual, section assembling the robotic drill for proper set up and handling.Per the clinical evaluation, it is suspected based on provided information on the incident that a user/technique variance was the root cause of the reported femoral bony defect.Reportedly, no interventions were performed due to the reported event.The cori user manual does warn to avoid contact with bone and tissue that are not intended to be cut, as the software only tracks bone which is intended to be cut.The reported patient impact was the resultant femoral bony defect.The requested operative notes and x-rays were not provided; however, there was a ¿perfect outcome per surgeon¿, without delay.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.This failure is an identified failure mode within the risk assessment released during the timeframe of the incident.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.

• 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: 12134893
• MDR Text Key: 260464535
• Report Number: 3010266064-2021-00528
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 11/23/2021
• 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: ROB20000/CORI ROBOTICS USA
• Patient Outcome(s): Required Intervention