MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10015

Device Problems Connection Problem (2900); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori-assisted tka procedure, the real intelligence robotic drill started to disconnect from the cori and started to appear the error in the software.Later, when the surgeon tried to take off the bur to see what was happened they saw that the ri robotic drill attachment was seized and the handpiece cannot be separated or recovered.Surgery was resumed after a greater than 30 minutes delay, with a change in surgical technique to manual procedure.Patient was not harmed beyond the reported problem.

Manufacturer Narrative

Section h10: the cori, real intelligence robotic drill attachment, part number rob10015, (b)(6), used for treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was confirmed, the drill attachment is stuck on the drill.It is noted that the drill attachment does not unlock when using the ¿unlock collet¿ feature on the ¿long attachment assembly¿ screen during kpc testing.When trying to load a burr while the timer was counting down, the motor did not push out and hold, instead it pushed back.When trying to run a case, there was a system timeout loop, that would not let the user continue.The drill was taken apart for further investigation.When taking apart the drill, the drill attachment was able to be removed.The drill attachment retaining nut was completely backed out and was measured to be.655in long which is above the specification of.627in +/-.002in.The drill¿s exposure motor was tested and was found to have been functioning properly.A known working drill attachment was used with the drill and the drill was able to pass kpc test and complete a case without error.The most likely cause of this event is the mechanical lock nut became loose due to vibration.The service record indicated the device met all specifications following completion of the service activity.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 found similar events.The scope of this case, part number, lot, or serial number is being evaluated by our internal quality processes and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.Refer to the real intelligence cori for knee arthroplasty user manual, section assembling the robotic drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Further investigation into the reported failure is being conducted to determine if additional actions are required.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• 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: 16039370
• MDR Text Key: 306040378
• Report Number: 3010266064-2022-00679
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2023
• 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: PN: ROB10013. SN: (B)(6); PN: ROB10014, LN: UNKNOWN; PN: ROB10024, SN: (B)(6)
• Patient Outcome(s): Hospitalization