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

Catalog Number	ROB10015
Medical Device Problem Codes	Connection Problem (2900); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka surgery, a "system time out" error was displayed.After this notification the real intelligence robotic drill did not function any more.They were able to take the burr out the real intelligence robotic drill but could not unlock the ri robotic drill attachment nor the real intelligence robotic drill tracker.They also tried to unlock them in the admin but did not work.The surgery was completed, after a non-significant delay, changing to manual procedure.No injuries were reported.
Additional Manufacturer Narrative
Section h10: the ri robotic drill attachment rob10015, sn (b)(6), used during treatment, was returned for evaluation.Nothing was visually identified that leads to the reported scenario.A functional evaluation was performed, and the reported scenario was confirmed, the drill attachment and the tracker could not be removed manually or following a kpc test.The reported problem of a "system timeout error" could not be confirmed.The drill was opened for further investigation.The exposure motor was tested and passed.The motors were removed, and it was noticed that the drill attachment¿s retaining nut was loose and therefore does not meet the specifications of 20 ft-lbs.The drill attachment was inspected further, and all bearings and spacers were intact and in the correct order.The drill attachment¿s retaining nut was fastened and a kpc test was performed which passed without any failures.The loading and unloading of the tracker and attachment can be performed without any problems occurring.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: (b)(4).

• 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: 18378320
• Report Number: 3010266064-2023-00240
• Device Sequence Number: 20727834
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• 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): 02/13/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/13/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RI CORI (PN: ROB10024, SN (B)(6)); RI ROB DRLL (PN: ROB10013, SN (B)(6)); RI ROB DRLL TRCKR (PN: ROB10014)
• Patient Sex: Unknown