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	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 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.
Event or Problem Description
It was reported that during a cori-assisted tka surgery, the real intelligence tablet, remained permanently on a black screen.After the tablet was unplugged from the console, the operation could be completed.The procedure was resumed after a significant delay.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Corrected data: d9 & h3 (device returned for analysis), h6 (component code, type of investigation, investigation findings, investigation conclusions).Updated results of investigation: the real intelligence tablet, rob10027, sn (b)(6), used in surgery, and was returned for evaluation.The external condition shows moderate signs of wear.The bottom of the tablet does not sit properly in the housing.The cable has a kink where it enters the tablet which could lead to the reported scenario.A functional evaluation was performed, and the reported scenario was confirmed.The tablet was connected to the console.The screen remained black.The lights on the console started to flash.The led on the back of the tablet turned from red to green and black to red.The flashing lights on the console was permanent.The touch function was still working.Moving the cable around did not change anything.The tablet screen remained black.The most likely cause of this incident is a broken internal wire in the cable assembly.There is no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review was performed by part number and similar complaints were identified.A review by lot/serial was performed and no similar complaints were identified.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The 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, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• 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: 21630283
• Report Number: 3010266064-2025-00068
• Device Sequence Number: 8925610
• Product Code: OLO
• UDI-Device Identifier: 00885556757451
• UDI-Public: 885556757451
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 04/29/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/29/2025
• 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: REAL INTELLIGENCE CORI, SN: (B)(6).
• Patient Sex: Unknown