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

Model Number ROB10035

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Unspecified Tissue Injury (4559)

Event Date 10/19/2020

Event Type  Injury  

Event 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 into soft tissue.It is unknown how was the procedure completed.

Manufacturer Narrative

H11: d1, d4, h5, h5: corrected information.

Manufacturer Narrative

Section h6 was updated.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.Use care when handling sharp objects such as the burs, irrigation hardline tubing, bone pins, and speed pins to prevent lacerations or puncture wounds.Refer to the cori surgical system user's manual for proper handling.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, 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" into soft tissue.It is unknown how the procedure was completed.It was communicated under the related master case that the requested medical documentation and drill were not available for inclusion in a medical investigation.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.No further medical assessment is warranted at this time.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.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).

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL
• Type of Device: 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: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 7634524980
• MDR Report Key: 10835428
• MDR Text Key: 216093840
• Report Number: 3010266064-2020-01993
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757505
• UDI-Public: 00885556757505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10035
• Device Catalogue Number: ROB10013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other