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

Model Number ROB10013

Device Problems Retraction Problem (1536); Connection Problem (2900)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, upon calibration of the real intelligence robotic drill they received the "retraction time verification error" message while attempting to calibrate.This message appeared after advancing through the test-spin page of set up.They initially attempted to surpass this step by pressing "continue" and following the prompts on the screen for drill registration again.Following three unsuccessful attempts to calibrate, they disconnected, disassembled and then reassembled and calibrated the same drill.This step allowed them to successfully advance through the registration screen.Then, during the bone removal phase, they began with milling the distal femur.As soon as the surgeon encountered bone with the burr, they received a "system time out error".They advanced by selecting "continue" on the screen and then they received another "system time out error" when the surgeon encountered bone again.They selected "continue" again and allowed the drill to recalibrate and then advanced with bone removal, but received a third "system time out error".They then attempted to advance by selected "continue" again, but this time, the drill would not recalibrate and a buffering-wheel appeared on the screen.After five seconds, they received the "system time out" message again.They attempted to advance again by selecting "continue" but the same buffering-wheel appeared again, and the same "system time out" message followed.After 3 more unsuccessful attempts, they disconnected, disassembled, reassembled and reconnected the same drill.When they reached the distal femur prep screen again, they switched to "visualize cut" tab and navigated a distal femur block in line with the planned cut.Then, they were able to successfully refine and remove the excess bone left from the saw blade and the holes for the 4-1 punch tool.Then, they advanced through the remainder of the case and cut as planned.While trialing, the patient's knee did not reach terminal extension since they had a significant flexion contracture present in which they did not fully correct with the original planned resection values, therefore they chose to go back into the planning screen and remove +2mm from the distal femur to correct the patient's significant deformity.When the surgeon attempted to mill the distal femur, the surgeon began with the lateral condyle, and was able to remove 1/2 of the +2mm of lateral condyle, when he received another "system time out" message.They advanced with "continue" and proceeded to mill more of the distal femur at the center of the knee, and received another "system time out".Again, they received another "system time out".After pressing continue, the surgeon was able to finish the distal milling without error.The procedure was completed with the same device with a significant delay.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

The 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.The drill produced a system timeout/drill deactivated message several times during a case.An engineering review was completed.The exposure motor passed encode and multi meter testing.The most likely cause of this event is the intermittent failure of the drill exposure motor encoder.A review of manufacturing 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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Based on the documentation provided, the clinical root cause of the reported events could not be definitively concluded; however, the ¿overused robotic drill¿ could not be ruled out as a potential contributing factor to the reported ¿issues¿.The additional distal femur resection was reportedly due to the significant pre-op varus deformity of 13 degrees.The patient impact beyond the reported errors resulting in a more complex procedure and subsequent greater than 30 minute surgical delay could not be determined, although reportedly, there was no patient harm due to the events.No further medical assessment can 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 robotic drill p/n rob10013, (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.The drill produced a system timeout/drill deactivated message several times during a case.An engineering review was completed.The exposure motor passed encode and multi meter testing.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 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.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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Based on the documentation provided, the clinical root cause of the reported events could not be definitively concluded; however, the ¿overused robotic drill¿ could not be ruled out as a potential contributing factor to the reported ¿issues¿.The additional distal femur resection was reportedly due to the significant pre-op varus deformity of 13 degrees.The patient impact beyond the reported errors resulting in a more complex procedure and subsequent greater-than-30-minute surgical delay could not be determined, although reportedly, there was no patient harm due to the events.No further medical assessment can 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, 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: 14232861
• MDR Text Key: 290276770
• Report Number: 3010266064-2022-00324
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 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-(B)(6)