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

Catalog Number	ROB10026
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a cori-assisted tka, the real intelligence foot pedal got stuck and would not raise up by itself.When getting stuck the user had to manually raise the pedal to make sure the burr would not spin.Surgery was performed, without any delay, with the same device.No patient complications were reported.
Additional Manufacturer Narrative
H3, h6: the real intelligence foot pedal, part number rob10026, serial number (b)(6) , 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 has identified prior events.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 sticking footswitch.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
H3, h6: the real intelligence foot pedal, part # rob10026, serial # (b)(6), used for treatment, was returned for evaluation.No system log files or screenshots were provided for investigation, as such a thorough investigation could not be performed.Should screenshots or system log files become available, the case can be reopened.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.Testing over several days did not observe the pedal getting stuck or needing to be lifted to stop burring.Although the reported problem was not confirmed through a visual or functional evaluation, it is possible that some blockage or debris around the pedal may have contributed to the pedal becoming stuck when pressed down.When the foot pedal was received, the body and pedals all appear to be clean and decontaminated, so any possible obstruction seems to have been cleared.Another possible contributing factor may have been related to an unknown electrical fault in the foot pedal receptacle on the front panel of the cori console used.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.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: 18313149
• Report Number: 3010266064-2023-00226
• Device Sequence Number: 12442070
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 00885556757444
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2024

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: ROB10026
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 02/22/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/05/2024; 02/22/2024
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: ROB10024 / SN: (B)(6)
• Patient Sex: Unknown