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

Catalog Number	ROB10026
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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 tka cori assisted surgery the cord of one (1) real intelligence foot pedal was pinched under the bed, cutting one of the wires inside the rubber casing.This caused the cori to display a blue manual image on the front screen, preventing the use of that foot pedal.The procedure was resumed after a non-significant delay by change to manual procedure.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: the real intelligence foot pedal, part number rob10026, serial number (b)(6), used for treatment, was returned for evaluation.The reported problem was visually confirmed.There is a split in the cable approximately 15 inches from the pedal strain relief, revealing the wires beneath.It appears like the cable sleeve was pinched and torn, as the wires are also compressed.A functional evaluation was performed.The foot pedal appears to function normally despite the cable damage.No errors were observed.Although the reported issue of a blue manual icon appearing was not able to be reproduced, the foot pedal's cable was found to be damaged and split.The cause of this issue seems to have been due to user error, as the report claims that the cable was pinched under the bed during use.Possible contributing factors for the blue manual icon appearing may have been related to a fault in the cori console or electrical discharge or interference caused by the cable being pinched and torn.A review of manufacturing records indicate 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 number 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 including a documented risk level.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 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: 21697185
• Report Number: 3010266064-2025-00077
• Device Sequence Number: 15761626
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 885556757444
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown