MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10033
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during cori tka procedure, while burring all under exposure mode on the tibia in an xr case, surgeon complained that the bur "skipped." surgeon said it skipped into bone that he needed to bur, with no ill effect.After he noticed it skipped, he stopped burring and completed the tibial cuts using manual tibial cut after milling, completed procedure using cori.No delay reported or additional complications were reported.
Additional Manufacturer Narrative
H11: d1, d4, h5, h8: corrected information.
Additional Manufacturer Narrative
Section h10: the product, real intelligence robotic drill (us), rob10013 used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.Master case contains log files, however did not provide any evidence to support the reported event.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may have been associated with user learning curve/improper method of burring implant region due to lack of familiarity/insufficient experience/training with the cori drill.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints found similar events.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.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, the bur ¿skipped into bone that he needed to bur, with no ill effect¿ during a cori xr tka procedure.Per the field report, the surgeon stopped burring after it ¿skipped¿ into the bone, performed the tibial cuts using the em xr jig, then completed the procedure with the cori.There was no reported surgical delay or impact on the case and/or patient as the bone was ¿sawed away¿.It was communicated that the requested medical documentation and drill were not available for inclusion in a medical investigation.However, it was reported that the surgeon was satisfied with the surgical outcome and no further interventions were required.Based on the information provided, the definitive root cause of the reported event could not be concluded; however, the cori with the ri drill provides 2x cutting volumes and >20% faster resection over the navio, therefore the increased burring/milling ability and the user learning- curve of the cori could not be ruled out as potential contributing factors to the reported event.The patient impact beyond the reported event with a modified surgical technique could not be determined.No further medical assessment is warranted at this time.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 or provided at a future date, this evaluation will be reopened for investigation.Internal complaint reference number: (b)(4) section g1 was corrected.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL
• 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; suite 100; austin, TX 78735 ; 5123913905
• MDR Report Key: 10835393
• Report Number: 3010266064-2020-01991
• Device Sequence Number: 4141630
• Product Code: OLO
• UDI-Device Identifier: 00885556757482
• UDI-Public: 00885556757482
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• 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,Followup
• Report Date (Section B): 05/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ROB10033
• Device Catalogue Number: ROB10013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 04/28/2022
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 11/19/2020; 05/04/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown