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

Catalog Number	ROB10035
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a cori assisted tka surgery, one (1) real intelligence 5 mm cylindrical bu popped out right before burring and would not seat properly.The procedure was resumed, after a non-significant delay, using a s+n backup device.No injury was reported as a result of this issue.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).H3, h6: the real intelligence 5 mm cylindrical bu, part number rob10035, lot number 51242294, used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.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 adequate.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 during surgical site assembly/disassembly or decontamination.Based on the investigation, no containment or corrective action is 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.

• Brand Name: REAL INTELLIGENCE 5 MM CYLINDRICAL BU
• 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: 20588586
• Report Number: 3010266064-2024-00212
• Device Sequence Number: 17781751
• Product Code: OLO
• UDI-Device Identifier: 00885556757505
• UDI-Public: 885556757505
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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 Catalogue Number: ROB10035
• Device Lot Number: 51242294
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAL INTELLIGENCE CORI: ROB10024, SN (B)(6).
• Patient Sex: Unknown