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

Model Number ROB10013

Device Problems Connection Problem (2900); Mechanics Altered (2984)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

The cori drill, used in 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 event was confirmed.At the start of the evaluation, the device failed testing and display critical error message.The message was acknowledged, the drill disconnected and reconnected, and tested again.The kpc was successfully performed.The drill passed testing and a case was review successfully.  it was found the exposure motor is working intermittently.Additionally, when the drill was disassemble, it was observed 2 bearings located in the nosepiece locking mechanism were stuck affecting the detachment of the long attachment.A supplemental report will be sent with the complete results of investigation when completed.Internal complaint reference number: (b)(4).

Event Description

It was reported that when the surgeon finished milling the medial distal femoral condyle and moved to the lateral during a cori assisted tka surgery, they received a system time out.They hit continue and proceeded without further issue.The procedure was completed, with a non-significant delay, using the same device.Patient was not harmed beyond the problem reported.Upon investigation, it was found that the exposure motor from the real intelligence robotic drill is working intermittently.

Event Description

It was reported that during a cori assisted tka surgery while mapping the tibia the entire tibia turned yellow as if it was all filled in.They turned on the green points and proceeded as normal without issue.When the surgeon finished milling the medial distal femoral condyle, moved to the lateral, they received a system time out.They hit continue and proceeded without further issue.The procedure was completed, with a non-significant delay, using the same device.Patient was not harmed beyond the problem reported.Upon investigation, it was found that the exposure motor from the real intelligence robotic drill is working intermittently.

Manufacturer Narrative

Results of investigation: the cori drill, pn rob10013, (b)(6), used in 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 event was confirmed.At the start of the evaluation, the device failed testing and display critical error message.The message was acknowledged, the drill disconnected and reconnected, and tested again.The kpc was successfully performed.The drill passed testing and a case was review successfully.It was found the exposure motor is working intermittently.Additionally, when the drill was disassemble, it was observed 2 bearings located in the nosepiece locking mechanism were stuck affecting the detachment of the long attachment.A review of manufacturing indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior 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.The most likely cause of this event is an electrical communication failure.Further investigation into the reported failure and remediation 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

H3, h6, h7, h9: the cori drill, pn rob10013, (b)(6), used in 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 event was confirmed.At the start of the evaluation, the device failed testing and display critical error message.The message was acknowledged, the drill disconnected and reconnected, and tested again.The kpc was successfully performed.The drill passed testing and a case was review successfully.It was found the exposure motor is working intermittently.Additionally, when the drill was disassemble, it was observed 2 bearings located in the nosepiece locking mechanism were stuck affecting the detachment of the long attachment.A review of manufacturing indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior 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 failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.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: 13939210
• MDR Text Key: 288121127
• Report Number: 3010266064-2022-00227
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• 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