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

Model Number ROB10024

Device Problems Intermittent Continuity (1121); Connection Problem (2900); Mechanics Altered (2984); Unintended Application Program Shut Down (4032)

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

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a cori-assisted total knee arthroplasty, the following errors were displayed: robotic drill critical error, system timeout error, communication failure error.This happened with two separate drills.At first, the system did not recognize either drill when plugging into the console.A reboot was performed and a drill diagnostics test was run for both, in which the critical drill errors were received.The system was rebooted again and a new case was added; the console recognized one of the drills but then a system timeout error kept appearing during the unlock drill step of setup/calibration.Surgery was completed, after a delay of less than 30 min, with manual instrumentation.There was no harm to the patient.

Event Description

It was reported that, during a cori-assisted total knee arthroplasty, the following errors were displayed: robotic drill critical error, system timeout error, communication failure error.This happened with two separate drills.At first, the system did not recognize either drill when plugging into the console.A reboot was performed and a drill diagnostics test was run for both, in which the critical drill errors were received.The system was rebooted again and a new case was added; the console recognized one of the drills but then a system timeout error kept appearing during the unlock drill step of setup/calibration.Surgery was completed, after a delay of less than 30 min, with manual instrumentation.There was no harm to the patient.Upon investigation, it was confirmed that both real intelligence robotic drills presented defective exposure motors; one of them presented a damaged pin 9 (sn =(b)(6) and the other one had all pins damaged (sn = (b)(6).

Manufacturer Narrative

The ri robotic drill, part number rob10013, serial number (b)(6), used in treatment was returned for evaluation.A relationship between the reported events and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problems were confirmed.All kpc tests failed during drill diagnostics prior to a robotic drill critical error.Test case setup could not be completed due to a system time out error loop.Substituting the exposure motor with a test lab motor corrected the problem.An engineering review was completed.The reported problem was confirmed.The exposure motor encoder was tested and found to be unresponsive.The most likely cause of this event is a faulty exposure motor connection.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.In the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that, during a cori-assisted total knee arthroplasty, several errors were displayed.Surgery was completed, after a delay of less than 30 min, with manual instrumentation.There was no harm to the patient.Further investigation into the reported failure is being conducted to determine if additional actions are required.The failure mode will continue to be closely monitored through complaint investigation 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: 15317205
• MDR Text Key: 298856820
• Report Number: 3010266064-2022-00587
• 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: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• 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
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: PN: ROB10013/SN: (B)(6); PN: ROB10024 / SN: (B)(6)
• Patient Outcome(s): Required Intervention