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

Model Number ROB10013

Device Problem Connection Problem (2900)

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

Event Date 11/15/2022

Event Type  Injury  

Event Description

It was reported that during a cori-assisted tka procedure, the surgeon was in the middle of burring the distal femur when the real intelligence robotic drill proceeded to stop working.The message that was given was ¿connection to the robotic drill is not detected and to reestablish the connection to continue¿.After many attempts and an attempt to run a kpc test on the drill, all efforts produced no results and the drill was unable to be used to complete the case.Surgery was completed after a non-significant delay, with manual procedure.The surgeon used manual instrumentation to finish all of the femur cuts as well as tibia cuts.Patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Case(b)(4).

Manufacturer Narrative

H3, h6.The real intelligence robotic drill, part # rob10013, serial # (b)(6), used for treatment, was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A system timeout error/drill deactivated message appeared at the beginning of a case.The drill led on the console was flashing.Swapping the exposure motor resolved this.An engineering review was completed.The reported problem was not confirmed.The exposure motor passed encoder and multi meter testing.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 intermittent issue with the drill exposure motor.A review of manufacturing records indicate the software 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.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.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

The real intelligence robotic drill, part # rob10013, serial # (b)(6), used for treatment, was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A system timeout error/drill deactivated message appeared at the beginning of a case.The drill led on the console was flashing.Swapping the exposure motor resolved this.An engineering review was completed.The reported problem was not confirmed.The exposure motor passed encoder and multi meter testing.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 records indicate the software 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: 16010125
• MDR Text Key: 305777829
• Report Number: 3010266064-2022-00675
• 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
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• 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: ROB10024/REAL INTELLIGENCE CORI.
• Patient Outcome(s): Other