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

Model Number ROB10013

Device Problems Unstable (1667); Connection Problem (2900); Unintended Application Program Shut Down (4032)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

It was reported that, during a cori-assisted tka procedure, the robotic drill attachment was unable to lock onto the real intelligence robotic drill and continued to loosen up during robotic drill calibration process.A system fault warning message communication failure: please contact robotics customer support continued to occurred even after changing to another drill attachment.After retrying calibration for the fourth time and afterwards.Surgery was completed after a non-significant delay, with a back-up device.Patient was not harmed.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The real intelligence robotic drill, part number rob10013, serial number (b)(6), intended for use in treatment, was returned for evaluation.The reported problems could not be confirmed with a visual inspection.The reported problem of the drill attachment not locking on was confirmed with a functional evaluation.During a test case and drill diagnostics, a drill attachment was able to be loaded but was unstable, without the tactile and audible locking in normally seen.The drill was disassembled and the rotating ring in the nose and motor housing was found to contain residue and was cleaned out.Degradation of the motor housing o ring was observed.When reassembled, the drill passed all kpcs and successfully completed a test case with a drill attachment securely locked on.The communication failure and calibration issues were not reproduced nor confirmed.A relationship between the reported event and the device was established.The most likely cause of this event is degradation of the o ring allowing ingress of material into the drill.Although the communication failure and calibration issues were not confirmed, contributing factors may be the residue in the motor housing causing intermittent electrical issues.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 review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Based on the investigation, the need for a corrective action is not recommended or required at this time.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: 16371659
• MDR Text Key: 309521596
• Report Number: 3010266064-2023-00023
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• 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
• Treatment: REAL INTELLIGENCE CORI, SN:(B)(6)