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

Model Number ROB10013

Device Problems Retraction Problem (1536); Connection Problem (2900); Unintended Movement (3026)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  Injury  

Event Description

It was reported that, during "buring" in a cori-assisted tka surgery, the real intelligence robotic drill extended to far and created a hole (red spot) in femur (the hole was filled with cement).The surgeon stated it was about 5mm deep and a nickle size wide.The system gave a drill disconnect error during buring process.They were unable to advance by clicking continue with foot pedal.There was no homing after continuing.They attempted to reattach the long attachment, which was unsuccessful.Therefore, they switched hand pieces.The procedure was finished with a smith and nephew back up devices without significant delays.The patient is stable.

Manufacturer Narrative

H3, h6: the cori drill, part number rob10013, (b)(6), used for treatment was returned for evaluation.There were no visual abnormalities or non-conformances.A functional evaluation of the drill was attempted but the reported robotic drill cable disconnected error could not be confirmed due to premature drill failure in both drill diagnostics (kpc testing) and when starting a case that prevented further testing.Screenshots of the case were provided for review.The robotic drill cable disconnected error as well as system time out error messages were confirmed in the femur bone removal screens.An overcut of the femur was confirmed in the backgrounds of all the system time out error message that occurred during femur bone removal.Log file review found that the robotic drill cable disconnected error and the system time out error messages were due to a known error that may be a result of an intermittent connection issue between the exposure motor and the console.This issue is under further investigation.The confirmed overcut that occurred among the system time out errors is also under further investigation by the software engineering team.Refer to the real intelligence cori for knee arthroplasty user manual (500230), ¿removing bone during tka¿ section for warnings and additional information.The real intelligence cori for knee arthroplasty user manual (500230) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The clinical/medical evaluation concluded: ¿based on the limited information provided, the root cause of the reported event could not be definitively concluded, and it is unknown if the user technique and/or device functionality were possible contributing factors to the reported event.The patient impact beyond the reported over-burring of femur, the cement-filled bone defect, and the 0-30 minute surgical extension using a backup device could not be determined.It was reported that the patient was stable with a normal outcome.No further medical assessment can be rendered at this time.¿ this situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the documented risk file requires further investigation and possible adjustment by the site quality team.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review found similar reports.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.This issue will be continuously monitored through complaint investigation and post market surveillance.

• 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: 12321184
• MDR Text Key: 266500572
• Report Number: 3010266064-2021-00602
• 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: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 89 KG