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

Model Number	ROB10018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during ukr surgery with cori, they planned and executed both femur and tibia cuts.During trialing of the femur, they noticed that the femur cuts and peg holes were "off" and the trial would not fit properly.They checked their checkpoint to look for tracker movement and this confirmed that the femur tracker did move by ~6mm.Prior to cutting, during refine mode, they checked the borders of the implant and they appeared to be what they anticipated.So, they advanced and executed without realizing there may had been movement right after refining or during the actual burr phase that went unnoticed until after the fact.Due to the tracker movement at this point of the case they changed to manual instrumentation.There was a delay greater than 30 minutes.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the cori femur tracker, pn rob10018, use in treatment, was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has concluded this was an isolated event.A historical capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.Although the reported problem was not confirm, factors that may have contributed to the reported symptom may have been associated with mishandling.Ensure that the tracker clamp is stabilized when tightening the tracker in the clamp.Refer to cori user's manual part: installing femur and tibia trackers.This failure is an identified failure mode within the risk assessment.Per complaint details, due to the tracker movement, they changed to manual instrumentation.There was a delay greater than 30 minutes.No other complications were reported.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: REAL INTELLIGENCE FEMUR TRACKER
• 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 ; 2905 northwest blvd ste 40; plymouth, MN 55441 ; 5123913905
• MDR Report Key: 11729799
• Report Number: 3010266064-2021-00306
• Device Sequence Number: 14394188
• Product Code: OLO
• UDI-Device Identifier: 00885556757376
• UDI-Public: 00885556757376
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ROB10018
• Device Catalogue Number: ROB10018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ROB20000/CORI ROBOTICS USA
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown