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

Catalog Number ROB10013

Device Problem Overheating of Device (1437)

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

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a cori-assisted tka, when cutting the tibia the whole real intelligence robotic drill got extremely hot and stopped working after some time.The bur was not irritated anymore and could be removed easily.There was no error, however, the bur did not start working again.In addition, after surgery the handpiece was checked in administrator mode, however, it was not possible to irritate the bur again.Surgery was performed after a non-significant delay, using manual instrumentation.No patient complications were reported.

Manufacturer Narrative

Section h10: the cori drill rob10013, sn(b)(6), used during treatment, was returned for evaluation.Nothing could be visually identified that contributes to the reported scenario.A functional evaluation was performed.The reported scenario can be confirmed, the drill was hot, and stopped working after some time.It was attempted to perform a kpc test which could not be completed as it was impossible to load the burr.The drill was opened, and the motors were removed.The exposure motor was tested and passed.The carriage was disassembled, and it was noticed that the collet shaft was slightly displaced.The carriage was reassembled and a kpc test was performed.It now is possible to load the burr.All test passed without any errors.A test case was completed without any failures.The loading and unloading of the burr were tested multiple times and passed.An engineering review was completed.The exposure motor was tested and found to be responsive.The most likely cause was that the collet shaft was out of place.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: 17886577
• MDR Text Key: 325107062
• Report Number: 3010266064-2023-00172
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 885556757321
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/06/2023
• 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: ROB10024 / SN: (B)(6).