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

Catalog Number ROB10013

Device Problems Break (1069); Overheating of Device (1437); Physical Resistance/Sticking (4012)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a cori-assisted tka, the real intelligence robotic drill passed calibration and seemed to be working fine.When the surgeon started to bur the distal femur, the handpiece was moving very slow and struggling to bur away the bone.It resected as planned and did not give any error, however it just seemed not to be spinning fast enough.The handpiece got very hot in the surgeons hands.Them, tried reinserting the bur and recalibrating.It passed, but continued not to work properly.Surgery was performed after a delay greater than 30 min, with a back-up device.No patient complications were reported.

Event Description

It was reported that, during a cori-assisted tka, the real intelligence robotic drill passed calibration and seemed to be working fine.However, when the surgeon started to bur the distal femur, the handpiece was moving very slow and struggling to bur away the bone.Even though it resected as planned and no error was triggered, it just seemed not to be spinning fast enough.The handpiece got very hot in the surgeon's hands.It was attempted to re-insert the bur and re-calibrate it, which passed, but continued not to work properly.Surgery was completed, after a delay greater than 30 min, with a back-up handpiece.No patient complications were reported.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6) , intended for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was confirmed with a functional evaluation.The bur speed is slow and intermittent.A functional evaluation was completed.A kpc test was attempted.It failed as a result of low bur speed.The drill was opened and the slip shaft is worn at the distal end and cracked.The wear was creating heat and the broken shaft caused an intermittent and slow rotation.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with wear and tear of the carriage bearings resulting in a broken slip shaft.Based on the investigation, no containment or corrective action is recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post-market surveillance activities.H10- additional information.H8- usage of device h11- corrected data.B5- describe event or problem.

• 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: 19032532
• MDR Text Key: 339245188
• Report Number: 3010266064-2024-00078
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 885556757321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/20/2024
• 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: PN: ROB10024 / SN: (B)(6)