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

Catalog Number ROB10013

Device Problems Connection Problem (2900); Noise, Audible (3273)

Patient Problem Laceration(s) (1946)

Event Date 08/16/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, the real intelligence robotic drill deactivated when beginning to bur the distal femur.We checked the long attachment and tried reinserting the bur/recalibrating.After recalibration the handpiece appeared to be working.As the surgeon began to bur, the bur started making a weird noise and then burred about a 1cm hole past any planned resection.The guard was on and the over resection showed on the screen and patient.The surgery was completed, after a non-significant delay, with a s+n back-up device.No injuries were reported.

Event Description

It was reported that, during a cori assisted tka surgery, the real intelligence robotic drill deactivated and gave "system time out" error message when beginning to bur the distal femur.We checked the long attachment and tried reinserting the bur/recalibrating.After recalibration the handpiece appeared to be working.As the surgeon began to bur, the bur started making a weird noise and then burred about a 1cm hole past any planned resection.The guard was on and the over resection showed on the screen and patient.The over resection was filled with cement.The surgery was completed, after a non-significant delay, with a s+n back-up device.No injuries were reported.

Manufacturer Narrative

H11 - corrected data.B5-describe event or problem: the over-resection was filled with cement.

Manufacturer Narrative

Section h3, h6: the real intelligence robotic drill, part # rob10013, serial # (b)(6), used for treatment, was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A visual inspection of the real intelligence cori, part # rob10024, serial # (b)(6) could not be performed as the device was not returned.A functional evaluation was performed on the real intelligence robotic drill, part # rob10013, serial # (b)(6).The reported problem was not confirmed.Testing of the drill (b)(6) found no errors, drill did not produce any abnormal noise and was not observed to disconnect when attempting to bur.A functional evaluation of the real intelligence cori, part # rob10024, serial # (b)(6) could not be performed as the device was not returned.A screenshot review was performed with the clinical team.Both the over resection and multiple "system timeout error¿ errors were confirmed from the screenshots.The drill was observed to be in the fully extended position according to the screenshot provided when the overcut occurred.A definitive cause could not be determined by the clinical team.Factors contributing to the over resection may have been associated with surgical technique or an improperly seated bur.An additional investigation was performed.Testing of the drill in order to reproduce the system time out error in a way that would cause the bur to extend while still burring.In each case, it was found that after the error occurs, the exposure position retracts which would prevent an overcut from occurring.A software discussion was performed.As no definitive log data was provided, a cause could not be established.Discussion with the software team suggests that factors contributing to the issue experienced where the bur was fully extended before presenting a "system time out" error may have been related to an anomalous error in the tcu functionality.Although provided log files and screenshots confirm that the over-resection did occur, no reasonable cause could be identified based on the received complaint information and investigation results.Review and discussions suggest that possible contributing factors may have been related to surgical technique, an improperly seated bur, or an anomalous tool control unit error.Investigation of the returned drill (b)(6) found no errors which could have contributed to the reported issue.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.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Cori is a surgical tool designed to provide assistance to the surgeon; it is not a substitute for the surgeon¿s experience and skill.The surgeon is responsible for implant planning and the conduct of the surgery during which cori is being used.The failure mode and associated risk have been anticipated within the risk file including a documented risk level.Based on the information provided, the definitive clinical root cause of the reported adverse event could not be concluded.Although we cannot rule out the possibility, of milling on the burr all screen, or the burr may have been unlocked causing it to not extend properly past the guard or else, the device remained in the exposure control mode during the procedure.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.H6: medical device problem code.

• 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: 17725330
• MDR Text Key: 323128497
• Report Number: 3010266064-2023-00153
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 885556757321
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: RI CORI(PN:ROB10024,(B)(6)).
• Patient Outcome(s): Required Intervention; Hospitalization