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

Model Number ROB10013

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, when the surgeon started cutting the femur in exposure mode (guard was on) during a cori assisted tka surgery, all of the sudden the lateral side of the femur started showing up dark red.They noticed that the real intelligence robotic drill was over resecting immediately and they pulled the drill off of the bone and let off the real intelligence foot pedal.When the surgeon pulled the drill away from the bone, the burr continued to spin even though he was no longer in vicinity of the knee and he also didn¿t have his foot on the pedal.The procedure was completed with manual instrumentation with a significant delay.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference number: (b)(4) section d4 was corrected according to the new information received.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6) used in treatment was returned for evaluation.The investigation did not visually or functionally identify the reported problem.The software files were downloaded from the device and provided for investigation.The screenshots could not confirm the reported overcut because the femur virtual model was not present at the time of the screenshot (this is due to heavy graphics elements, throwing the automatic screenshot timing off).The reported ¿burr continued to spin even though he was no longer in vicinity of the knee and he also didn¿t have his foot on the pedal¿ could not be confirmed.However, further investigation of the log files has been conducted by software engineering and it has been determined that this issue is likely to be an occurrence of a known software issue.The drill, footpedal (pn: rob10026, sn: (b)(6)), and console (pn: rob10024, sn: (b)(6)) used in this case were returned and all devices operated as intended.The burr continuing to spin outside of the cut zone could not be reproduced.The clinical/medical evaluation concluded: ¿based on the information provided, the root cause of the reported event could not be definitively concluded; however, user technique cannot be ruled out as a contributing factor to the reported event.The patient impact beyond the reported over-resectioned femur, significant ( > 30-minute) surgical delay and modified surgical procedure with manual instrumentation could not be determined.Reportedly, the patient was not harmed beyond the reported problem but the current patient status is unknown.No further medical assessment can be rendered at this time.¿ in the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.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: 14626733
• MDR Text Key: 293559025
• Report Number: 3010266064-2022-00459
• 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,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• 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
• Treatment: CORI ROBOTICS USA, (B)(6) ; REAL INTELLIGENCE FOOT PEDAL, (B)(6)
• Patient Outcome(s): Required Intervention