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	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that when checking trays of new shipment, the real intelligence robotic drill tracker was bent and unable to be used.As this was noticed in a non-surgical environment, there was not patient involvement.
Additional Manufacturer Narrative
H3, h6: the real intelligence robotic drill tracker rob10014 lot 20dst0005 intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was confirmed.The tip of one of the four flat marker connectors has been damaged/removed.The other 3 connectors are intact.A functional evaluation was performed.Complaint owned flat markers were attached to the remaining 3 connectors to evaluate fit.The flat markers were able to be attached and detached with minimal subjective force.A dimensional assessment was completed on the remaining 3 connectors.The dimension affecting the fit of the flat marker was within tolerance.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.The most likely cause of this event is an extremely tight flat marker fit requiring a tool to remove the flat marker and resulting in damage to the flat marker connector.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.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.

• 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: 13339519
• Report Number: 3010266064-2022-00047
• Device Sequence Number: 17166414
• 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: K201022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 20DST0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/10/2022
• 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: ROB20000-CORI ROBOTICS USA
• Patient Sex: Unknown