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

Catalog Number	ROB10026
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that, during a real intelligence cori assisted tka surgery, the black foot button of one (1) real intelligence foot pedal triggered permanently on its own, which made it impossible to continue with the operation.Despite disconnecting several times, the problem could not be fixed.The procedure was resumed after a non-significant delay changing to a manual procedure technique, and no injuries were reported as a result.
Additional Manufacturer Narrative
Section h4 was updated.Section h10: the real intelligence foot pedal, part number rob10026, serial number (b)(6), intended for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.A complaint history review was performed by part number and similar complaints were identified.A review by serial was performed and no similar complaints were identified.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 an intermittent connection to the console.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
Corrected data: d9 & h3 (device returned for analysis), h6 (type of investigation, investigation conclusions).Updated results of investigation: the real intelligence foot pedal , rob10026, (b)(6), used in surgery, was returned for evaluation.The foot pedal has small blank spots at the bottom of it.Nothing was visually identified that leads to the reported scenario.A functional evaluation was performed, and the reported scenario was not confirmed.The foot pedal was connected to the test box.The lights indicated that the foot pedal works as intended.A test case was performed which was be completed without any failures occurring.The foot pedal functioned as intended.No observation of the foot pedal being triggered permanently occurred during the testing.Although the reported problem could not be confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may have been associated with user error or a connection issue between the foot pedal and the console.A review of manufacturing records indicates the device met all specifications upon release into distribution.A complaint history review was performed by part number and similar complaints were identified.A review by serial was performed and no similar complaints were identified.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 completed.Prior escalation actions are not applicable to the scope of the reported complaint.Although no further action will be taken at this time the issue will be continuously monitored through complaint investigation and post market surveillance.

• Brand Name: REAL INTELLIGENCE FOOT PEDAL
• 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: 20985230
• Report Number: 3010266064-2024-00260
• Device Sequence Number: 8465811
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 885556757444
• 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,Followup
• Report Date (Section B): 04/30/2025

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
• Device Catalogue Number: ROB10026
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: Not provided; 04/28/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/14/2025; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB10024 / SERIAL # (B)(6).
• Patient Sex: Unknown