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

Model Number ROB10015

Device Problem Defective Device (2588)

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

Event Date 05/05/2021

Event Type  Injury  

Event Description

It was reported that, during a cori-assisted tka surgery, the swap bur button icon was pressed by accident as it is right next to the planning button.The case was sent back to the bur selection screen and the recalibrate step for the real intelligence robotic drill was necessary, then a calibration error message was displayed and was solved through troubleshooting.The case was exit and re-entered.Upon unlocking the drill a drill disconnect error message was displayed.The drill attachment was checked to see if it was fully looked and the case was exit, the drill was unplugged and plugged back in, the drill attachment was locked and the case was re-entered.A second drill disconnect error message was displayed when unlocking the drill for bur loading.After troubleshooting another drill disconnect error was displayed at the unlock screen (case-(b)(4)).It is unknown if this issue was caused by the real intelligence cori (case-(b)(4)).The drill was swapped, but the long attachment, tracker frame or the exposure guard were not swapped.At this point, the surgeon decided to finish the case with manual instrumentation.No significant delays (fewer than 30 minutes) were reported and the patient was not harmed.Additionally, after the case, the real intelligence robotic drill was assembled and when pressing unlock to load the burr, it was felt that the drill attachment rotated as if the unlocking mechanism of the drill caused the long attachment to rotate (case-(b)(4)).It is unknown if the drill attachment also contributed to this issue (case-(b)(4)).

Manufacturer Narrative

H3, h6: the ri robotic drill attachment (us) rob10015, s/n (b)(6) used for treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A kpc test was run and the test passed.The drill attachment functioned as intended without any connection errors during testing.Nothing was identified that contributed to the reported problem.A review of the patient case screenshots confirms the reported allegation of "drill disconnect" errors.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with a loose connection.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.A review of prior escalation actions found no actions applicable to the scope of this case.The user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that during a cori-assisted tka surgery, a calibration error message was displayed which was solved through troubleshooting.The case was exited and re-entered.Upon unlocking the drill, a drill disconnect error message was displayed.The drill attachment was checked to see if it was fully locked and the case was exited, the drill was unplugged and plugged back in, the drill attachment was locked and the case was re-entered.A second drill disconnect error message was displayed when unlocking the drill for bur loading.After troubleshooting another drill disconnect error was displayed at the unlock screen.It is unknown if this issue was caused by the real intelligence cori.The drill was swapped, but the long attachment, tracker frame or the exposure guard were not swapped.At this point, the surgeon decided to finish the case with manual instrumentation.No significant delays (fewer than 30 minutes) were reported and the patient was not harmed.Additionally, after the case, the real intelligence robotic drill was assembled and when pressing unlock to load the burr, it was felt that the drill attachment rotated as if the unlocking mechanism of the drill caused the long attachment to rotate.It is unknown if the drill attachment also contributed to this issue.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and 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: 11858355
• MDR Text Key: 260546396
• Report Number: 3010266064-2021-00395
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 05/06/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other