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

Model Number ROB10013

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted surgery, the robotic drill went through registration and calibration just fine.Once they got to the distal burring portion of the case, the bur would throw outside of the drill guard and will spin/cut when pointed toward the ceiling, but would not spin or cut when pointed downward or on the bone.The same thing happened during the robotic drill diagnostic tests.The procedure was completed with manual instrumentation without delay.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, rob10013, (b)(6) used for 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.Confirmed issue during kpc.Drill passed all parameters, entered test spin.Device performed the same way as described in complaint summary, but bur did not fall out.Drill was disassembled and a pin was missing from the motor.The most likely cause of this event is an assembly error.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 this case.The user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines".The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the documented risk file will undergo further investigation by the site quality team.Per complaint details from the us, it was reported that during a cori assisted surgery, the robotic drill went through registration and calibration just fine.Once they got to the distal burring portion of the case, the bur would throw outside of the drill guard and will spin/cut when pointed toward the ceiling, but would not spin or cut when pointed downward or on the bone.The same thing happened during the robotic drill diagnostic tests.The procedure was completed with manual instrumentation without delay.The patient was not harmed beyond the reported problem.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.

• 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: 13591150
• MDR Text Key: 286056712
• Report Number: 3010266064-2022-00134
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• 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: ROB10024-(B)(4); ROB20000-(B)(4)
• Patient Outcome(s): Other