MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TABLET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	ROB10027
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set-up for a cori assisted surgery, the screen and real intelligence tablet flickered, so that it was impossible to perform the procedure.A standard/manual instrumentation was used and the surgery was completed, after a non-significant delay.After the tm inspection, it turned out that the problem is the tablet.After disconnecting it and replacing it for another system, it works properly.No injury or harm were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3: the sample is under evaluation by manufacturing site.H6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Additional information: d10 (concomitant device added).Corrected data: h6 (health effect - impact code, component code, type of investigation, investigation findings, investigation conclusions).Updated results of investigation: the real intelligence tablet, part number rob10027, serial number (b)(6), intended for treatment was returned for evaluation.The reported problem was confirmed with a visual inspection.The cable has a kink where it enters the tablet.The reported problem was confirmed with a functional evaluation.The tablet was connected to the console.An image appeared and the touch screen worked as intended.When moving the tablet/cable during use, the screen turned black and the lights on the console started to flash.The console reset itself and the image appeared.This occurred every time the cable was moved.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with damage to the cable through wear over time.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.
Additional Manufacturer Narrative
Section h4 (device manufacture date) was updated.Internal complaint reference: (b)(4).

• Brand Name: REAL INTELLIGENCE TABLET
• 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: 20830494
• Report Number: 3010266064-2024-00241
• Device Sequence Number: 8730256
• Product Code: OLO
• UDI-Device Identifier: 00885556757451
• UDI-Public: 885556757451
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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: ROB10027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/20/2024; Not provided
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/26/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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: PN: ROB10024 / SN: (B)(6)
• Patient Sex: Unknown