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

Catalog Number	ROB10015
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during cori assisted tka surgery, while burring, the real intelligence robotic drill was disconnected due to an error connection and it was noticed that the ri robotic drill attachment was stuck with the handpiece.It was tried to disassemble it with the handpiece diagnostics but it was not possible.Surgery was resumed after a non-significant delay by manual procedure.Patient was not harmed as consequence of the problem.
Additional Manufacturer Narrative
Section h10: the cori drill attachment rob10015, sn (b)(6), used during treatment, was returned for evaluation.The reported scenario could not be visually confirmed.A functional evaluation was performed, and the reported scenario can be confirmed.The drill attachment and the tracker could not be removed manually or following a kpc test.The drill was opened for further investigation.The exposure motor was tested and passed.When removing the motor, it was noted that the drill attachment¿s retaining nut is loose and therefore does not meet the specification of 20 ft-lbs.The drill attachment¿s retaining nut was fastened to specification.A kpc test and a test case were performed, both tests could be completed without any failures occurring.An engineering review was completed.The exposure motor was tested and found to be responsive.The most likely cause of the drill attachment becoming stuck onto the drill is the mechanical lock nut became loose due to vibration.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 scope of this complaint however no further escalation action is required.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Further investigation into the reported failure is being conducted to determine if additional actions are required.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Section h6 was updated.Section h10 (updated results of investigation): the cori drill attachment (b)(6), used during treatment, was returned for evaluation.The reported scenario could not be visually confirmed.A functional evaluation was performed, and the reported scenario can be confirmed.The drill attachment and the tracker could not be removed manually or following a kpc test.The drill was opened for further investigation.The exposure motor was tested and passed.When removing the motor, it was noted that the drill attachment¿s retaining nut is loose and therefore does not meet the specification of 20 ft-lbs.The drill attachment¿s retaining nut was fastened to specification.A kpc test and a test case were performed, both tests could be completed without any failures 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 real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".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: 18212853
• Report Number: 3010266064-2023-00210
• Device Sequence Number: 15064051
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 06/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 11/15/2023
• 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: 12/14/2023; 06/20/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/20/2023; 06/24/2024
• 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: RL INT CORI (B)(6).; RL INT RBTC DRLL TRCKR (B)(6).; RL INT RBTC DRLL(B)(6).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown