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

Model Number ROB10013

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 08/26/2020

Event Type  Injury  

Event Description

It was reported that as they were preparing the tibial cut during a cori tka procedure, they had some bone remaining on the lateral tibia.The surgeon was using speed control and the tunneling technique.The bone was very sclerotic and as the surgeon was tunneling, the bur bounced off the hard bone and went into the patellar tendon.The surgeon continues to be concerned about the speed of the bur and bouncing off of sclerotic bone with the potential risk of injuring the patellar tendon and other soft tissues.He has expressed that he wishes there was ability to adjust variable speed of bur (other than with pressure on foot pedal as that is very difficult and clunky to be precise with the pressure of his foot).The surgeon had to hard power off the cori and reboot.There was a delay of less than 30 minutes.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial unknown and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation, or field service report.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 potential lack of familiarity or experience with the cori product line, or improper method of milling bone tissue.The cori surgical technique manual (500230) provides a "warnings" column under the "removing bone during tka" section of the ifu that cautions the surgeon to " always use retractors to protect soft tissue and ligaments from damage due to inadvertent movement of the robotic drill and bur." and "cori application software only tracks operative bone.Avoid contact to ligaments, tendons, and bone that are not intended to be cut".Per the clinical evaluation, the cori¿ with the ri drill/new bur designs provides 2x cutting volumes and 29% faster resection over the navio¿.It was reported that the requested op-notes and/or imaging would not be provided for inclusion in the medical investigation and the complaint device has remained in use at the facility without further issues.The increased burring/milling ability and the user learning- curve of the cori could not be ruled out as potential contributing factors to the reported event.The patient impact beyond the reported events would not be anticipated as the patient was reportedly ¿doing well¿ with no additional intervention required.No further medical assessment is warranted at this time.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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 10766697
• MDR Text Key: 214084924
• Report Number: 3010266064-2020-01946
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

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?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention