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

Model Number ROB10013

Device Problem Suction Problem (2170)

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

Event Date 11/11/2020

Event Type  malfunction  

Event Description

It was reported that during a cori tka procedure, there was debris "flying" off the sterile field and bouncing back into the field from the drill/handpiece when milling bone.This is the seventeenth of seventeen incidents.No other complications were reported.

Manufacturer Narrative

The product, ri robotic drill, rob10013, used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may be associated with improper assembly of tubing resulting in inadequate irrigation and suction, failure to clear surfaces of residual debris using irrigation, suction and/or hand tool orientation with respect to bone surface, limiting debris.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 10935125
• MDR Text Key: 219175338
• Report Number: 3010266064-2020-02079
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA/SN(B)(6)