MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL TRACKER

Model Number	ROB10014
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the set up for a cori lab, the real intelligence robotic drill was already assembled and the ri robotic drill attachment was locked onto the drill and was not able to remove the attachment case (b)(4).The real intelligence robotic drill tracker had a bent flat marker point case (b)(4).The lab was completed using a s+n back-up devices.No patient was involved.
Additional Manufacturer Narrative
H3, h6: the cori drill array p/n rob10014 intended for use in treatment was returned.A relationship between the reported event and the device was established.The reported problem was confirmed.The drill tracker array has a bent back left marker post.A functional evaluation was performed.A case was run and the failed.The reported problem was confirmed.The drill tracker array post is bent and the camera will not recognize the drill during a case.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.The most likely cause of this event was improper handling of the drill tracker array.Care and caution should be exercised during the surgical assembly and use.Refer to the cori surgical system user's manual for proper handling.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.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL TRACKER
• Common Device Name: REAL INTELLIGENCE ROBOTIC DRILL TRACKER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11921376
• Report Number: 3010266064-2021-00438
• Device Sequence Number: 4439733
• Product Code: OLO
• UDI-Device Identifier: 00885556757338
• UDI-Public: 00885556757338
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: ROB10014
• Device Catalogue Number: ROB10014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1