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

Model Number ROB10013

Device Problems Intermittent Continuity (1121); Connection Problem (2900)

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

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, while burring the tibia in a cori assisted tka surgery, an error message prompted that the robotic drill was disconnected.They attempted to calibrate the real intelligence robotic drill again, but the same error occurred and the surgeons were asked to re-register the checkpoints again on the patient's bone, knee center and flexion range.At last they could not proceed to assess post-op stress gap because the drill disconnect error appeared several times (case (b)(4)) and they also received a communication failure error (case (b)(4)).A backup drill was available, but the surgeon decided to completed the procedure with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.After the surgery, a new robotic drill was used to test the system and successfully passed the calibration page and no error was found.

Manufacturer Narrative

The ri robotic drill, (hong kong), part number rob10013, serial number (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.A kpc test failed during drill diagnostics prior to a robotic drill critical error.Encoder b failed pin test.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.Refer to the user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.As a result of the risk assessment the documented risk file will undergo further investigation and possible adjustment by the site quality team.Per complaint details from hong kong, it was reported that during a cori assisted tka surgery, several drill disconnect error messages appeared.They also received a communication failure error.A backup drill was available, but the surgeon decided to completed the procedure with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.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.

Manufacturer Narrative

H3, h6: the ri robotic drill, (hong kong), part number rob10013, serial number: (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.A kpc test failed during drill diagnostics prior to a robotic drill critical error.Encoder b failed pin test.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 associated with a failure of the drill exposure motor due to the thermo-mechanical stress induced within the motor at the encoder and electrical noise on the console error status inputs to the drill exposure motor encoder.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.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action already implemented.Refer to the user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Continuous improvements have been made to the cori robotic drill and manufacturing processes to reduce drill disconnection error messages.These improvements consisted of: 1.A hardware update to the cori console to reduce noise on the internal electronics.2.An update to the cori system¿s software and firmware to improve the user experience when error messages are displayed, and 3.A hardware update to the cori drill to reduce mechanical stress on drill exposure the motor.The first two improvements are fully deployed.The third improvement is being deployed for new orders and as drills are returned for routine servicing.Also, smith+nephew is voluntarily performing a recall/field notification for the cori real intelligence robotic drill.Should any additional information be received the complaint will be reopened.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: 14539044
• MDR Text Key: 292959233
• Report Number: 3010266064-2022-00406
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/29/2022
• Supplement Dates Manufacturer Received: 10/21/2022; 01/16/2024
• Supplement Dates FDA Received: 10/24/2022; 01/17/2024
• 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: Unknown
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA, SN: (B)(6).
• Patient Outcome(s): Required Intervention