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

Model Number ROB10013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Muscle/Tendon Damage (4532)

Event Date 09/30/2020

Event Type  Injury  

Event Description

It was reported that, during cori tka procedure, while preparing the tibial cut, they had some bone remaining on the lateral tibia.Surgeon and resident took guard off and went to speed control.The bone was very sclerotic and the resident, under the surgeon¿s guidance attempted to use the tunneling technique on speed control and the bur bounced off the hard bone and went into the patellar tendon.The surgeon was 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.Surgeon had to hard power cori off and reboot.Delay less than 30 minutes reported.

Manufacturer Narrative

H3, h6: the cori drill p/n: rob10013, sn: (b)(6) used in treatment was returned for evaluation.A visual and functional evaluation on the real intelligence robotic drill was attempted.No abnormalities were visually identified.The drill threw a ¿robotic drill critical error¿ every time it was plugged in, and the functional evaluation could not be performed to address the reported concern that the drill¿s bur speed resulted in the bur bouncing off the sclerotic bone into the patellar tendon.This error is unrelated to the reported issue.Although the reported problem could not be confirmed, the most likely cause of the bur bouncing off into the patellar tendon could be due to hard bone, and the tendons not being adequately protected when burring.Refer to the real intelligence cori for knee arthroplasty user manual (500230), performing total knee arthroplasty (tka for warnings when removing bone during tka.Always use retractors to protect soft tissue and ligaments from damage due to inadvertent movement of the robotic drill and bur.Cori application software only tracks operative bone.Avoid contact to ligaments, tendons, and bone that are not intended to be cut.The clinical/medical evaluation concluded: ¿per complaint details, when the resident attempted to remove sclerotic bone from the lateral tibia using speed control, the ¿bur bounced off the hard bone and went into the patellar tendon¿ and the surgeon had to reboot the system.However, it was communicated that the procedure was completed with the same device, the event required no additional intervention, the wound closed well with normal sutures and ¿patient is doing well¿.Reportedly the surgeon is concerned about the speed of the bur and bouncing off sclerotic bone.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 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 this to be an isolated event.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: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 7634524980
• MDR Report Key: 10709026
• MDR Text Key: 212242873
• Report Number: 3010266064-2020-01909
• 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: 08/02/2022

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?: No
• 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: 08/01/2022
• Supplement Dates FDA Received: 08/02/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention