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

Model Number ROB10013

Device Problem Mechanics Altered (2984)

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

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

The cori drill used for treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.A kpc test was run and the test failed.The reported problem was confirmed.When the drill was plugged in the error "robotic drill disconnect" pops up.An engineering evaluation was performed.The reported problem was confirmed.After further evaluation it was found that the exposure motor has an encoder failure.The tcu is expecting a signal from the encoder but does not receive one.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 associated with the part with the failure modes 'connection problem ' identified similar events.A relationship between the reported event and the device was established as the exposure motor was found to have an encoder error.Further investigation into the reported failure is being conducting to determine if additional actions are required.Our reference number: (b)(4).

Event Description

It was reported that before a cori tka procedure, the robotic drill had connection issues.The console will not recognize it being plugged in after several attempts were made to unplug and plug in.They opened up and used backup robotic drill to proceed with a delay of less than 30 minutes.No other complications were reported.This is the first incident of two.Investigation found that the drill had internal motor issues.

Manufacturer Narrative

The cori drill p/n rob10013, sn (b)(6) used for treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.A kpc test was run and the test failed.The reported problem was confirmed.When the drill was plugged in the error "robotic drill disconnect" pops up.An engineering evaluation was performed.The reported problem was confirmed.After further evaluation it was found that the exposure motor has an encoder failure.The tcu is expecting a signal from the encoder but does not receive one.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 associated with the part with the failure modes 'connection problem ' identified 5 similar events between (b)(6) 2020 and (b)(6) 2020.A relationship between the reported event and the device was established as the exposure motor was found to have an encoder error.Further investigation into the reported failure is being conducting to determine if additional actions are required.

Manufacturer Narrative

The cori drill p/n rob10013, (b)(6) used for treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.A kpc test was run and the test failed.The reported problem was confirmed.When the drill was plugged in the error "robotic drill disconnect" pops up.An engineering evaluation was performed.The reported problem was confirmed.After further evaluation it was found that the exposure motor has an encoder failure.The tcu is expecting a signal from the encoder but does not receive one.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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 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.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: 11438958
• MDR Text Key: 241313112
• Report Number: 3010266064-2021-00172
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• 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: 10/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• 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
• Patient Sequence Number: 1