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

Model Number ROB10013

Device Problems Connection Problem (2900); Physical Resistance/Sticking (4012)

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

Event Date 02/17/2022

Event Type  malfunction  

Event Description

It was reported that during set up for a cori assisted tka surgery, while calibrating the real intelligence robotic drill, it would not unlock to insert burr, it did not give any error message just no unlock.They ran a drill diagnostic and the only thing that did not check out was the max speed.They had to wait for another cori tray being processed.The procedure was completed, with a significant delay, using a s+n back-up device.Patient was not harmed beyond to the problem reported.After the case they calibrated the suspect handpiece and first time received a robotic drill critical error but every time after it did unlock and lock the burr.Gave it about ten tries and always worked.This is the first of two cases.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The real intelligence robotic drill, rob10013, sn (b)(6), intended for use 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.Could not load bur, ran kpc without bur and the system showed all except "minimum homing torque" as failed.After kpc, created test case, was able to load bur.No errors were encountered during test case.Re-entered kpc, was able to load bur and pass kpc at this point, however there was still some resistance.Disassembled drill and found contamination along the drill's carriage.Once that was cleaned off, no issues occurred during bur load.The drill passed kpc and no issues occurred during a test case.The most likely cause of this event is inadequate cleaning and sterilization.Refer to the cori surgical system instrument kit cleaning and sterilization guide and surgical system user's manual for proper handling of the handpiece.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 has identified prior events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.

Manufacturer Narrative

H3, h6, h7, h9 : the real intelligence robotic drill, rob10013, (b)(6) intended for use 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.Could not load bur, ran kpc without bur and the system showed all except "minimum homing torque" as failed.After kpc, created test case, was able to load bur.No errors were encountered during test case.Re-entered kpc, was able to load bur and pass kpc at this point, however there was still some resistance.Disassembled drill and found contamination along the drill's carriage.Once that was cleaned off, no issues occurred during bur load.The drill passed kpc and no issues occurred during a test case.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.Refer to the cori surgical system instrument kit cleaning and sterilization guide and surgical system user's manual for proper handling of the handpiece.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 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.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: 13715311
• MDR Text Key: 286925897
• Report Number: 3010266064-2022-00182
• 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: 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

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 09/07/2022; 01/10/2024
• Supplement Dates FDA Received: 09/08/2022; 01/11/2024
• 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)