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

Model Number ROB10013

Device Problems Unstable (1667); Calibration Problem (2890); Physical Resistance/Sticking (4012)

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

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during the calibration set up for a cori assisted surgery, the real intelligence robotic drill notified that it was almost time to service the drill but could still continue, however, when they hit continue, it would just quit out of case and not let them move forward.They went to admin screen to run a test on the handpiece and the bur would not even lock in to move through the test and the test kept failing.The ri robotic drill attachment was stuck on the real intelligence robotic drill after they tried calibrating.The procedure was completed, without delay, by changing in surgical technique.

Manufacturer Narrative

Results of investigation: the cori drill, p/n rob10013, (b)(6), intended for used in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed and the reported problem was confirmed.The drill was disassembled and the drill attachment was removed.It was found that the nut that rides the exposure motor lead screw was broken.This nut attaches to the carriage which allows it to move.The broken nut will not allow the carriage to travel to the position that allows the bur to be inserted, therefore confirming the complaint.Contributing factors for the broken lead screw nut could be general wear and tear or improper handling of the drill.Refer to the real intelligence cori for knee arthroplasty user manual ((b)(4)) for instructions on proper handling of the drill in disassembly and cleaning.The user manual also provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the documented risk file requires further investigation and possible adjustment by the site quality team.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• 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: 12964517
• MDR Text Key: 285237302
• Report Number: 3010266064-2021-00851
• 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
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 08/20/2022
• 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: PN: ROB10014 / SERIAL NUMBER: UNKNOWN
• Patient Outcome(s): Other