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

Catalog Number ROB10013

Device Problems Break (1069); Connection Problem (2900); Mechanics Altered (2984)

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

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported that during cori assisted tka surgery, the real intelligence robotic drill motor suddenly stopped milling.A slight click inside the handpiece can be heard when the orange footswitch was pressed.The back and forth retraction of the milling still worked.Surgery was resumed without any delay by manual procedure.Patient was not harmed as consequence of the problem.

Manufacturer Narrative

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

Manufacturer Narrative

Section d9, d10, and h6 were updated.Section h10: the cori drill rob10013, (b)(6), used during treatment, was returned for evaluation.Nothing was visually identified that contributes to the reported failure.A functional evaluation was performed.The reported scenario can be confirmed.A key performance characteristics (kpc) test was performed during which the burr did not spin.The drill motor was heard attempting to spin.The drill was opened for further investigation.The motors were removed, and the exposure motor was tested and passed.When removing the drill motor, parts of the bearing fell out.It was also noted that the extension shaft is deformed/melted.The carriage was disassembled.The back bearing was completely broken, and the slip shaft is worn out.All defective parts were replaced and a kpc test was performed and passed without any failures occurring.Afterwards a test case was performed which could be completed without any failures occurring.An engineering review was completed.The exposure motor was tested and found to be responsive.The most likely cause for the reported failure is a melted slip shaft and a broken bearing.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 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: 18076449
• MDR Text Key: 327474603
• Report Number: 3010266064-2023-00191
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: CORI (PN: ROB10024/ SN: (B)(6))
• Patient Outcome(s): Other