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 06/14/2022

Event Type  Injury  

Manufacturer Narrative

Initial 30 day mdr.

Event Description

It was reported that, when beginning to mill the second tibia twin peg hole in a cori assisted tka surgery, a system time out error occurred.They hit continue and the real intelligence robotic drill reinitialized.As soon as the surgeon touched the bone with the burr, they received the error again.They checked that the burr was locked in, tried to burr again and received the time out again.They ensure that the long attachment was on and they hit continue again and received the time out error.After they hit continue, they went to the change burr screen to switch the long attachment.When they tried to unlock the burr they received the system timeout followed by an internal error.As there was no backup available, the procedure was completed with manual instrumentation with a 10 minutes delay.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, p/n rob10013, sn: (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 critical error appeared during kpc testing and a system timeout during a case.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 the failure of 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.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 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, recurrent system time-out errors occurred during the tibial twin peg hole drilling of the cori assisted tka followed by an internal error.Per the field report, a backup tray was not available, ¿so the surgeon finished the case manually¿ with a 5-10 minute surgical delay and without patient harm.It was communicated that the requested clinical documentation was not available.Patient impact beyond the reported recurrent system time-outs, internal error, and subsequent modified surgical procedure which incurred a 5-10 minute surgical delay would not be anticipated as the procedure was reportedly completed manually without patient injury.No further medical assessment could be rendered at this time.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, p/n (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 critical error appeared during kpc testing and a system timeout during a case.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 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, recurrent system time-out errors occurred during the tibial twin peg hole drilling of the cori assisted tka followed by an internal error.Per the field report, a backup tray was not available, ¿so the surgeon finished the case manually¿ with a 5-10 minute surgical delay and without patient harm.It was communicated that the requested clinical documentation was not available.Patient impact beyond the reported recurrent system time-outs, internal error, and subsequent modified surgical procedure which incurred a 5-10 minute surgical delay would not be anticipated as the procedure was reportedly completed manually without patient injury.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.H10- additional information d10- concomitant medical products h11- corrected data.B2- outcomes attributed to adverse event.

• 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: 14928520
• MDR Text Key: 295314239
• Report Number: 3010266064-2022-00515
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

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: 06/14/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 01/23/2024
• Supplement Dates FDA Received: 12/20/2022; 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: REAL INTELLIGENCE CORI (B)(6).
• Patient Outcome(s): Required Intervention; Hospitalization