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

Model Number ROB10013

Device Problems Unstable (1667); Connection Problem (2900)

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

Event Date 10/20/2022

Event Type  Injury  

Event Description

It was reported that, during the set-up for a cori assisted tka surgery, a real intelligence robotic drill would not unlock and a ¿robotic drill critical error: the robotic drill has an internal error¿ message was received.It was attempted to exit the case disassemble the drill, and reassemble/re-enter the case, without any success.Then a drill diagnostic test was attempted, unfortunately, when the collet was unlocked, the system would not accept the burr.The entire collet would slide to the back of the drill.In addition, the real intelligence robotic drill attachment and tracking frame were locked onto the drill.Surgery was performed manually after a non-significant delay.No harm to the patient or further complications reported.

Manufacturer Narrative

Reference number: (b)(4).

Manufacturer Narrative

The real intelligence robotic drill, part number rob10013, serial number (b)(6), intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual, section assembling 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 within the product risk profile.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an exposure motor encoder failure.Based on the investigation, the need for a corrective action is not recommended or required at this time.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.

Manufacturer Narrative

H3, h6: the cori, real intelligence robotic drill, part number rob10013, sn(b)(6), intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was confirmed.Multiple kpc tests and cases were completed without any errors.A burr was able to be loaded without issue multiple times.The drill was taken apart for further evaluation and it was found that the exposure motor had failed.Although the drill was functioning, it sounds as if exposure motor is behaving intermittently.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.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the real intelligence cori for knee arthroplasty user manual, section assembling 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.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

Manufacturer Narrative

The cori, real intelligence robotic drill, part number rob10013, sn:(b)(6) , intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was not confirmed.Multiple kpc tests and cases were completed without any errors.A burr was able to be loaded without issue multiple times.Although the reported problem was not confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may be associated with an intermittent 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 real intelligence cori for knee arthroplasty user manual, section assembling 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: 15786920
• MDR Text Key: 303551422
• Report Number: 3010266064-2022-00658
• Device Sequence Number: 1
• Product Code: OLO
• 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
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention