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

Catalog Number ROB10015

Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907); Mechanical Jam (2983)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that, during a cori assisted tka surgery, when burring the distal femur, the bur made a grinding noise and the screen showed ¿internal system error¿.The case had to be switched to manual from that point on, after a non-significant delay, as the handpiece could not be recovered.After the case, the bur was unable to be removed, so the ri robotic drill attachment and real intelligence robotic drill tracker are stuck on the real intelligence robotic drill as well.No injuries to the patient were reported.

Manufacturer Narrative

Additional information: h6 (type of investigation), h10 (results of investigation) h3, h6: the ri robotic drill attachment, part number (b)(4), serial number (b)(6), used for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was confirmed with a functional evaluation.A grinding noise was observed at the beginning of kpc.The bur and drill attachment could not be removed manually nor through kpc unlock.The head of the bur had to be cut off.The attachment was removed through disassembly of the drills motors.Following removal of the drill attachment the retaining nut was found to have loosened beyond the required torque specification and a bearing had broken into pieces.There were no signs of threadlock on the nut.Debris from the bearing was in the cavity of the carriage collet preventing the bur from being removed.The carriage was cleaned and reassembled.The respective drill then passed kpc and a case with no issues nor errors with a substitute attachment.Screenshots and system log files are required to complete a thorough investigation.In absence of the xsessions file, a review of the provided system log files was completed with the software support team.The reported problem was not confirmed.Without xsession logs, we are unable to pinpoint the exact cause of these errors.Should the missing files become available, the case can be reopened.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with a loose drill attachment retaining nut.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.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.G2.

Manufacturer Narrative

H10: h3, h6: the ri robotic drill attachment, part number rob10015, serial number (b)(6), used for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was confirmed with a functional evaluation.A grinding noise was observed at the beginning of kpc.The bur and drill attachment could not be removed manually nor through kpc unlock.The head of the bur had to be cut off.The attachment was removed through disassembly of the drills motors.Following removal of the drill attachment the retaining nut was found to have loosened beyond the required torque specification and a bearing had broken into pieces.There were no signs of threadlock on the nut.Debris from the bearing was in the cavity of the carriage collet preventing the bur from being removed.The carriage was cleaned and reassembled.The respective drill then passed kpc and a case with no issues nor errors with a substitute attachment.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with a loose drill attachment retaining nut.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.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through 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: 18563392
• MDR Text Key: 333470232
• Report Number: 3010266064-2024-00013
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• 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
• Treatment: ROB10013/REAL INTELLIGENCE ROBOTIC DRILL; ROB10014/REAL INTELLIGENCE ROBOTIC DRILL TRACKER; ROB10024/REAL INTELLIGENCE CORI