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

Catalog Number	ROB10015
Medical Device Problem Codes	Mechanical Jam (2983); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
It was reported that during a cori-assisted tka, the real intelligence robotic drill suddenly made loud squeaking noises and then blocked completely along with the ri robotic drill attachment and real intelligence robotic drill tracker.It can no longer be dismantled.Surgery was performed, without any delay, changing to manual procedure.Patient is doing well.
Additional Manufacturer Narrative
Section h10: the real intelligence 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 key performance characteristics (kpc) test.Loud noises were not heard while running the drill.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 retaining nut did not have loctite on it.When trying to disassemble the drill attachment it was noticed that the bearings and spacers were stuck.The wiper was removed, and the bearings and spacers were pressed out from the top.It was also noticed that the drill attachment was worn on the inside (behind the threads).The spacers and bearings were inspected and were in specification.The drill attachment was reassembled, and the retaining nut was replaced and fastened to specification.A kpc test was performed which passed.The loading and unloading of the tracker and attachment could be done without any problems.An engineering review was completed.The exposure motor was tested and found to be responsive.The most likely cause of this event is a loose drill attachment retaining nut.A review of manufacturing and service records indicates 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: 18637588
• Report Number: 3010266064-2024-00016
• Device Sequence Number: 7725757
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 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: Not provided
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/04/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORI (PN: ROB10024/ SN: (B)(6)).; RI ROBOTIC DRILL (PN: ROB10013/ SN: (B)(6)).; RI ROBOTIC DRILL TRACKER (PN: ROB10014).
• Patient Sex: Unknown