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

Catalog Number ROB10013

Device Problems Overheating of Device (1437); Physical Resistance/Sticking (4012)

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

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during cori assisted tka surgery, the real intelligence robotic drill was overheating and the bur wasn't spinning nor being exposure properly.Surgery was resumed after a non-significant delay and continued by manual procedure.Patient was not harmed as consequence of the problem.

Manufacturer Narrative

Section h10: the cori drill rob10013, sn (b)(6), used during treatment, was returned for evaluation.Nothing was visually identified that contributed to the reported failure.A functional evaluation was performed.The reported scenario could be confirmed, the drill was overheating and not spinning properly.It was noticed that during a kpc test, the handpiece was loud and was hot to the touch.The drill was taken apart for further investigation.It was noted that there were 2 bearings in the carriage that had disintegrated.After swapping the 2 shaft bearings from the carriage, the handpiece passed all kpc tests and a test case without any other failures or overheating.The most likely cause for this event is due to the broken shaft bearings within the carriage.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.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The real intelligence cori for knee arthroplasty user manual (500230 rev d) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, 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: 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: 18140833
• MDR Text Key: 328177947
• Report Number: 3010266064-2023-00199
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/05/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: REAL INTELLIGENCE CORI, SN:(B)(6)
• Patient Outcome(s): Other