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

Model Number ROB10013

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Date 12/28/2022

Event Type  Injury  

Event Description

It was reported that, during a cori-assisted tka procedure, the burr over-resected the distal femur.Surgeon pulled the handpiece away to investigate and the burr was extended out of the drill guard by about 3mm.Surgery was completed after a non-significant delay, with a back-up device.Patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: additional information in d9 and d10.H3, h6.The real intelligence robotic drill, part number rob10013, serial number (b)(6), used for treatment, was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was not confirmed with a functional evaluation.The drill passed all diagnostic tests with both the provided drill attachment and a lab drill attachment.Validation was performed by setting the exposure extension to multiple positions and measuring against the drill guard, and the drill exposed properly.A test case was run to the cut stages, and the burr appeared to be extending appropriately as compared to the virtual representation on screen.A review of the log files showed that multiple calibration verification errors happened during the case.No other errors affecting the drill occurred.A relationship between the reported event and the device could not be established.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with improper loading of the burr during case setup.The clinical/medical investigation concluded that the patient impact beyond the reported over-resected distal femur, use of a backup device with a change from original plan, and the 0-30 minute surgical delay cannot be determined, but the current health status is reported as ¿healthy¿.Refer to the real intelligence cori for knee arthroplasty user manual, section loading the burr for proper set up and handling, including pressing and turning the burr into the drill until a click is heard/felt.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Based on the investigation, the need for a corrective action is not 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.H11: corrected information in h6 (health effect - clinical code and health effect - impact code).

• 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16195815
• MDR Text Key: 307601018
• Report Number: 3010266064-2023-00014
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: ROB10015 / SERIAL # (B)(6); ROB10024 / SERIAL # (B)(6)
• Patient Outcome(s): Other