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

Model Number ROB10015

Device Problems Physical Resistance/Sticking (4012); Unintended Application Program Shut Down (4032)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during set-up for a tka procedure, the system continued to produce an ¿internal error¿ message while attempting to unlock the real intelligence robotic drill to insert the bur.After several failed attempts, the scrub tech attempted to disassemble the drill, but the ri robotic drill attachment would not disassemble.The procedure was finished with a smith and nephew back up device.As this happened before surgery, there was not patient involvement.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill attachment, part number rob10015, serial number (b)(6), intended for use in treatment, was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was not confirmed with a functional evaluation.The retaining nut was torqued to specification and the drill attachment was able to be attached/detached during drill diagnostics.No internal errors occurred during a test case.A relationship between the reported event and the device could not be established.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an intermittent exposure motor issue with the drill used in the case.No issues were found with the drill attachment.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 has identified prior events.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Based on the investigation, the need for a corrective action is not 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.

• 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: 16050263
• MDR Text Key: 306909830
• Report Number: 3010266064-2022-00685
• Device Sequence Number: 1
• Product Code: OLO
• 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: 01/27/2023

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 Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/27/2023
• 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: REAL INTELLIGENCE CORI; REAL INTELLIGENCE ROBOTIC DRILL; REAL INTELLIGENCE ROBOTIC DRILL TRACKER