MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 5 MM CYLINDRICAL BUR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10035
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during set up for a cori assisted surgery, they were opening the real intelligence 5 mm cylindrical bur, when they took it out of the sterile pack the lid of the tube slid off and the burr fell on the ground.The procedure was completed with the same device without significant delay.The patient was not harmed.
Additional Manufacturer Narrative
H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that during set up for a cori assisted surgery, they were opening the real intelligence 5 mm cylindrical bur, when they took it out of the sterile pack the lid of the tube slid off and the burr fell on the ground.The procedure was completed with a smith and nephew back up device without significant delay.The patient was not harmed.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since there was a sterile back up device available, and the patient did not suffer any risk because of this incident.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.

• Brand Name: REAL INTELLIGENCE 5 MM CYLINDRICAL BUR
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 12565275
• Report Number: 3010266064-2021-00697
• Device Sequence Number: 13839801
• Product Code: OLO
• UDI-Device Identifier: 00885556757505
• UDI-Public: 00885556757505
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: ROB10035
• Device Catalogue Number: ROB10035
• Device Lot Number: 1099740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORI ROBOTICS USA-ROB20000