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

Catalog Number	ROB10015
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a cori assisted tka surgery, a real intelligence robotic drill would not burr the green of the bone and the pegs for the distal femur.It was also burred incorrectly and not flat on the tibia.The procedure was resumed, after a non-significant delay, changing to manual procedure.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Section d10 was updated.Section h10: the real intelligence robotic long attachment, rob10015, (b)(4), used during surgery, was returned for evaluation.The reported scenario cannot be visually confirmed.A functional evaluation was performed, and the reported scenario can be confirmed, during a test case, the green area of the femur could not be burred.After the test case, it was attempted to remove the long attachment and the tracker, but they had gotten had stuck.The drill was opened for further investigation.The exposure motor was tested and passed.The motors were removed, and the drill was inspected.No defects were found.The carriage had to be removed to free the long attachment and tracker.The drill attachment¿s retaining nut as found to be out of specification and was loose.The retaining nut did not have any loctite present on it.The inside of the drill attachment was inspected, and all parts were within specification.The drill attachment¿s retaining nut was fastened to specification.A test case was performed and could be completed without any issue.The drill was able to burr the green of the femur without issue.An engineering review was completed.The exposure motor was tested and found to be responsive.The most likely cause of this event is associated with a loose drill attachment retaining nut.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.The review determined that prior escalation actions are applicable to the part number or serial number and scope of this complaint, and no further escalation action is required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.As part of corrective actions, continuous improvements have been made to the assembly process.The assembly work instruction has been updated to include the application of a thread-lock compound to the drill attachment retaining nut during assembly.The failure mode will continue to be monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: case-2024-00215218-1 sections d4 and g4 were corrected.

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• Common Device Name: 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: 19767925
• Report Number: 3010266064-2024-00157
• Device Sequence Number: 15648069
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 885556757345
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RI CORI (PN: ROB10024/ SN: (B)(6)); RI ROBOTIC DRILL (PN: ROB10013/ SN: (B)(6))
• Patient Sex: Unknown