MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10015

Device Problem Material Separation (1562)

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

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a cori assisted surgery, they heard unusual noises from the real intelligence robotic drill like metal on metal, then the drill was very hot.The wiper detached from the ri robotic drill attachment, it was moving through the bur and fell inside the patient.After this the drill stopped working.The procedure was completed with manual instrumentation with a delay greater than 30 minutes.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Additional information: d4, d10.H3, h6: the ri robotic drill attachment (israel) rob10015, s/n (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.The drill attachment was removed.There was an occlusion with the bearings as one bearing case was completely detached fused to the bur causing the wiper to break off of the crown when the bur was exposed.An additional investigation was performed.The customer supplied photos and videos were reviewed.The reported problem was confirmed.The drill attachment shaft bearings exploded causing excessive heat.The heat fused the bearing racer on to the bur, when the bur was exposed the bearing racer would not fit through the wiper opening causing it to rip the wiper off of the crown.The most likely cause of this event is mechanical component failure.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 and the documented risk level is still adequate.Per complaint details from israel, it was reported that during a cori assisted surgery, they heard unusual noises from the real intelligence robotic drill like metal on metal, then the drill was very hot.The wiper detached from the ri robotic drill attachment, it was moving through the bur and fell inside the patient.The wiper was removed using scissors.After this the drill stopped working.The procedure was completed with manual instrumentation with a delay greater than 30 minutes.The patient was not harmed beyond the reported problem.

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• 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: 13087655
• MDR Text Key: 282775011
• Report Number: 3010266064-2021-00905
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• 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: ROB20000/CORI ROBOTICS USA