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

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	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The sample is under evaluation by manufacturing site.
Event or Problem Description
It was reported that, during cori assisted tka surgery, the robotic drill kept coming in and out of view with the camera.They wiped the flat markers off and ensured they were seated, but still experienced the drill coming in and out of view with the camera even though it was in a direct line of site with the camera.Upon visual inspection, it appeared that the real intelligence robotic drill tracker was bent.Procedure was resumed, after a non-significant delay, using the same device.No patient complications were reported.
Additional Manufacturer Narrative
Section h10: the real intelligence robotic drill tracker, rob10014, lot 20fumc001 used for treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.There is slight appearance of one bent flat marker connector.Most prominent when flat marker was placed on the connector.A functional evaluation was performed.The reported problem was confirmed.A case was created.Drill tracker array would float in and out of view.The most likely cause of this event is the connector becomes bent as a result of tight fitting flat markers and the need for a tool to remove.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Care and caution should be exercised during surgical assembly and use of the drill tracker array.Refer to the cori surgical system user's manual for proper handling.This failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.Internal complaint reference number: (b)(4).

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL TRACKER
• Common Device Name: 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: 14072119
• Report Number: 3010266064-2022-00278
• Device Sequence Number: 2632198
• Product Code: OLO
• UDI-Device Identifier: 00885556757338
• UDI-Public: 00885556757338
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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
• Device Lot Number: 20FUMC001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORI ROBOTICS USA-(B)(4)
• Patient Sex: Unknown