MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 6 MM CYLINDRICAL BUR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10036
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka surgery, a real intelligence 6 mm cylindrical bur broke off at the connection.The piece of the broken bur was stuck into the handpiece.No piece fell into the patient.Surgery was finished after a non-significand delay with a sn back-up device.No harm to the patient or further complications reported.
Additional Manufacturer Narrative
Section d10 was updated.Section h10: the real intelligence 6 mm cylindrical bur, part number rob10036, lot number 50926756, used for treatment was not returned for evaluation.An image was provided.A relationship between the reported event and the device could not be established.The reported problem could not be confirmed with a visual inspection.The image provided does not confirm the device broke.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still within the product risk profile.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with product mishandling.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).

• Brand Name: REAL INTELLIGENCE 6 MM CYLINDRICAL BUR
• 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: 15664165
• Report Number: 3010266064-2022-00635
• Device Sequence Number: 20429567
• Product Code: OLO
• UDI-Device Identifier: 00885556757512
• UDI-Public: 00885556757512
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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 Expiration Date: 03/01/2026
• Device Model Number: ROB10036
• Device Catalogue Number: ROB10036
• Device Lot Number: 50926756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2021
• 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: REAL INTELLIGENCE CORI, SERIAL (B)(6).; REAL INTELLIGENCE ROBOTIC DRILL, SERIAL (B)(6).
• Patient Sex: Unknown