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 06/21/2022

Event Type  Injury  

Event Description

It was reported that, during a cori assisted tka procedure, after the surgeon had finished burring distal femur, finished the cuts with his 5:1 block, and within the first few seconds of burring all on the tibia, the real intelligence robotic drill stopped working.The surgeon thought it was the footpedal, so they unplugged and replugged the pedal and hit continue.The surgeon continued to try to burr the tibia but then a ¿system time out¿ error popped up on the screen.Surgeon hit the black foot pedal to ¿continue¿ but then the error continued to pop up.They unplugged and replugged the drill in and the error continued to pop up.Later on, they quit out of the case, unplugged and replugged the drill, went back into the case to recalibrate, but the error continued to pop up.They then exited out, restarted the robot, went back into the case and the error still occurred.The surgeon did not have a backup drill, so he finished his tibia cut with manual instrumentation and achieved the desired outcome.There was a delay of a couple minutes.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The ri robotic drill, 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.Kpc test failed with a 'robotic drill critical error.Attempted a case and received a 'system time out' error when pressing 'next' at the set up screen.The drill case was opened and the drill motor was removed.The slip shaft had broken and the slip shaft pin was bent.The pin must have scored/gouged the inside of the case housing surrounding the drill motor.The most likely cause of this event is drill slip shaft pin has worked loose and contacted the inside shaft wall causing the slip shaft to break.The cause is assembly related.Production did not secure the pin.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 this case.Refer to the real intelligence cori for knee arthroplasty 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.Per complaint details, after the completion of the distal femur burring and cuts with 5:1 block, the device did not perform as intended for the tibial burring and the issue was unresolved with troubleshooting.Reportedly no backup drill was available; therefore, the cori assisted tka was abandoned and the surgery was concluded with manual procedure within a 0-30 minute surgical extension (¿delay of a couple minutes¿) without patient injury due to the reported event.It was communicated that the requested clinical documentation was not available.Patient impact beyond the reported 0-30 minute surgical delay, abandoning the cori system and subsequent use of manual instrumentation to conclude the tka procedure would not be anticipated as manual procedure/standardized instrumentation is an approved surgical technique and no patient harm was alleged due to the reported event.The current patient status is unknown.No further medical assessment could be rendered at this time.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.

Manufacturer Narrative

H3, h6: the ri robotic drill, 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.Kpc test failed with a 'robotic drill critical error.' attempted a case and received a 'system time out' error when pressing 'next' at the set up screen.The drill case was opened and the drill motor was removed.The slip shaft had broken and the slip shaft pin was bent.The pin must have scored/gouged the inside of the case housing surrounding the drill motor.The most likely cause of this event is drill slip shaft pin has worked loose and contacted the inside shaft wall causing the slip shaft to break.The cause is assembly related.Production did not secure the pin.Another factor 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 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.Per complaint details, after the completion of the distal femur burring and cuts with 5:1 block, the device did not perform as intended for the tibial burring and the issue was unresolved with troubleshooting.Reportedly no backup drill was available; therefore, the cori assisted tka was abandoned and the surgery was concluded with manual procedure within a 0-30 minute surgical extension (¿delay of a couple minutes¿) without patient injury due to the reported event.It was communicated that the requested clinical documentation was not available.Patient impact beyond the reported 0-30 minute surgical delay, abandoning the cori system and subsequent use of manual instrumentation to conclude the tka procedure would not be anticipated as manual procedure/standardized instrumentation is an approved surgical technique and no patient harm was alleged due to the reported event.The current patient status is unknown.No further medical assessment could be rendered at this time.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.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.H11- corrected data, b2- outcomes attributed to adverse event, g2- report source.

• 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: 15070956
• MDR Text Key: 296287537
• Report Number: 3010266064-2022-00528
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• 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: ROB10024 / SN: (B)(6) (SOFTWARE: 1.4.3.8)
• Patient Outcome(s): Required Intervention; Hospitalization