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); Mechanics Altered (2984)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that, when the bone removal stage was entered in a cori-assisted surgery, it was possible to burr for about 20 seconds.After that, it was noticed that the burr stopped extending past the exposure sleeve, even after it was confirmed that everything was in view.It was noticed that the burr was moving in-and-out very slightly.It was seen to be stuck on a loop where it would extend and retract about 1mm repeatedly from the real intelligence robotic drill ((b)(4)).The robotic drill was unplugged and plugged back in.The case was re-entered after the system had shut down and the procedure was finished with the same devices without significant delays (fewer than 30 minutes).The patient was not harmed.During investigation, it was found that the real intelligence robotic drill had a exposure motor of the device failure.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number sn (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 problem was confirmed.A case was created and a system timeout was immediately encountered.There device was immediately met with a "system timeout" notification, followed by a flickering between two connection states.This is due to the complaint drill's exposure motor experiencing a failure.The most likely cause of this event is associated with an electrical component failure.A review of the customer provided log files did not reveal any information regarding the failure of this event, as there were no files pertaining to this complaint event.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.This failure is an identified failure mode within the risk assessment and the anticipated risk level is still adequate.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint.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.

Event Description

It was reported that, when the bone removal stage was entered in a cori-assisted surgery, it was possible to burr for about 20 seconds.After that, it was noticed that the burr stopped extending past the exposure sleeve, even after it was confirmed that everything was in view.It was noticed that the burr was moving in-and-out very slightly.It was seen to be stuck on a loop where it would extend and retract about 1mm repeatedly from the real intelligence robotic drill.The robotic drill was unplugged and plugged back in.The case was re-entered after the system had shut down and the procedure was finished with the same devices without significant delays (fewer than 30 minutes).The patient was not harmed.During investigation, it was found that the real intelligence robotic drill had a exposure motor of the device failure.Upon further investigation, it was found that the drill led on the console was flashing upon connection to the console.A kpc test was run and passed.The reported problem was confirmed.A case was created and a system timeout was immediately encountered.There device was immediately met with a loop between a checkmark and an "x" in the connection screen.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (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 problem was confirmed.A case was created and a system timeout was immediately encountered.There device was immediately met with a "system timeout" notification, followed by a flickering between two connection states.This is due to the complaint drill's exposure motor experiencing a failure.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.This failure is an identified failure mode within the risk assessment and the anticipated risk level is still adequate.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.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.H11: corrected data.Updated section h6.

• 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: 13572822
• MDR Text Key: 286512773
• Report Number: 3010266064-2022-00118
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• 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: 08/12/2021
• 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: Unknown
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1