MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10013

Device Problems Break (1069); Difficult to Insert (1316); Unintended Movement (3026)

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

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, the real intelligence robotic drill did not capture the burr, and created error messages consistently.They tried to run diagnostics, but were unable to capture the burr in the handpiece.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.

Event Description

It was reported that, during a cori assisted tka surgery, the real intelligence robotic drill did not capture the bur and they were not able to insert the bur into the handpiece.They tried to run diagnostics, but were unable to capture the burr in the handpiece.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.

Manufacturer Narrative

Sections b5 and h6 were updated according to the new information received.Internal complaint reference number: (b)(4).

Manufacturer Narrative

The cori drill, pn rob10013, sn(b)(6), used in treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported event was confirmed visually and functionally.When a kpc was try, the bur was able to be inserted, but would not be lock/secure.The device was disassemble to inspect the components, and the drill motor slipshaft was found to be broken.As the exposure mechanism is not tied to the slipshaft directly, when the carriage was commanded to expose for the insert of the bur, it was able to by pulling the fractured slipshaft with it.There was no obstruction in front of the leadscrew that would lead to a jam when exposing forward.This allow the bur to be inserted properly, however, would not allow the lock/secure of it.When the carriage retracts to secure the bur, the broken slipshaft would be in the way.This can cause a binding between the slipshaft and splinshaft/carriage.With the carriage unable to retract due to the obstruction, the bur was unable to be secured.The drill was retest with a good tester drill motor, and it operated as design.The bur was secured and the drill passed all testing.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 has identified prior 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 failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.The most likely cause of this event is the broken drill motor slipshaft obstruction caused the bur no to be lock/secure.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.

Event Description

It was reported that, during a cori assisted tka surgery, the real intelligence robotic drill did not capture the bur and they were not able to insert the bur into the handpiece.They tried to run diagnostics, but were unable to capture the burr in the handpiece.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.Upon investigation, it was found that the bur would not be lock/secured since the drill motor slipshaft was found to be broken, when the carriage retracts to secure the bur, the broken slipshaft would be in the way.This can cause a binding between the slipshaft and splinshaft/carriage.With the carriage unable to retract due to the obstruction, the bur was unable to be secured.

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Manufacturer Narrative

H3, h6: the cori drill, pn rob10013, (b)(6), used in treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported event was confirmed visually and functionally.When a kpc was try, the bur was able to be inserted, but would not be lock/secure.The device was disassemble to inspect the components, and the drill motor slipshaft was found to be broken.As the exposure mechanism is not tied to the slipshaft directly, when the carriage was commanded to expose for the insert of the bur, it was able to by pulling the fractured slipshaft with it.There was no obstruction in front of the leadscrew that would lead to a jam when exposing forward.This allow the bur to be inserted properly, however, would not allow the lock/secure of it.When the carriage retracts to secure the bur, the broken slipshaft would be in the way.This can cause a binding between the slipshaft and splinshaft/carriage.With the carriage unable to retract due to the obstruction, the bur was unable to be secured.The drill was retest with a good tester drill motor, and it operated as design.The bur was secured and the drill passed all testing.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 has identified prior 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 failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.The most likely cause of this event is the broken drill motor slipshaft obstruction caused the bur no to be lock/secure.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: REAL INTELLIGENCE ROBOTIC DRILL
• 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: 13776227
• MDR Text Key: 287258630
• Report Number: 3010266064-2022-00189
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2022
• 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
• Treatment: CORI ROBOTICS (B)(4)