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

Model Number ROB10013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/04/2021

Event Type  Injury  

Event Description

It was reported that during a cori assisted ukr surgery the real intelligence robotic drill made a large over resection on the medial side, it was proceed to checked the checkpoints and no movement had occurred.In addition the anterior leg hole went from being in the blue directly to white when it was refined, it appeared the diameter of the hole increased when it was refined.The procedure was completed without delay using the same device.No other complications were reported.There was made a drill diagnostic testing after the case and everything came back as normal.

Manufacturer Narrative

Section b5 was updated with the new information received.Internal complaint reference number: (b)(4).

Event Description

It was reported that during a cori assisted ukr surgery the real intelligence robotic drill made a large over resection on the medial side, which was corrected with a little bit of extra cement (the doctor mentioned that the bone quality was poor).They proceeded to check the checkpoints and no movement had occurred.In addition the anterior leg hole went from being in the blue directly to white when it was refined, it appeared the diameter of the hole increased when it was refined.There was no error displayed on the system.The procedure was completed without delay using the same device.No other complications were reported.They performed a drill diagnostic test after the case and everything came back as normal.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, pn: rob10013, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore a visual and functional inspection could not be performed.However, the case files were provided and reviewed to confirm the reported problem.Screenshots confirmed over-resected bone along the medial edge of the condyle, as well as the posterior end of the condyle.The checkpoints were verified to be on the bone in casevisualizer.Screenshots confirmed that the knee was in 10 degrees varus.This significant degree of varus could be indicative of osteophytes on the medial condyle because they tend to occur where there is excessive friction between the joint surfaces.A potential cause could be that the osteophytes were removed after femur free collection, which may have led to the over-resection (red) of the bone.The red bone is an area that is typically a softer bone, making the bone more susceptible to accidental resection when removing the osteophytes that are in proximity to this soft bone.Reference the cori user's manual for osteophyte removal prior to registration with the cori system.Before collecting range of motion and free collection data, prominent spurs or osteophytes are to be removed.Remove intracondylar, medial, and lateral osteophytes to avoid impingement with the tibial spine or cruciate ligaments, as well as peripheral osteophytes that may interfere with the collateral ligaments and capsule.It is crucial that all osteophytes are removed from the entire medial edge of both the femur and tibia, in order to assess joint stability reliably.It was confirmed that the diameter of the anterior lug hole appeared larger in the bone model refinement screenshots.Further review of the screenshots found that the bone model refinement had occurred right after the burring of the lug hole.It appears there was some red around the interior perimeter of the lug hole, indicating the hole was burred outside of what was planned.The user then went in to bone model refinement again, where the bur and the guard had swept the interior of the lug hole, which made the lug hole white.A potential cause of the larger lug hole could be a situation where the surgeon was quickly moving the active bur around the lug hole site and the bur did not have enough time to retract, thus creating a larger lug hole than planned.Or the drill could have been rammed into the hole with the guard.According to the cori user's manual, the user should avoid quick passes of the tool over the surface.To remove bulk bone, a slow, methodic ¿plunge and drag motion¿ through to the cortical layer, will remove bone with the greatest efficiency.The bur remains protruded only until it has reached the target surface, and the bur exposure actively adjusts so that cutting beyond the target surface is minimized.As described in the cori user's manual, the bone model refinement stage presents a model of the operative surface where the bur tip or the guard (in exposure mode and not rotating) of the robotic drill is moved over the bone surface where layers of bone are removed from the virtual model to depict the current state of the bone surface.As the robotic drill tip is moved over the bone surface, layers of bone are removed from the on-screen model.Therefore, the virtual "refining" of the anterior lug hole turned the red bone to white bone to reflect the updated physical bone model on the screen.Based on the information provided, the medical/clinical investigation concluded the following: the patient¿s poor bone quality, user technique and/or procedural variance could not be ruled out as possible contributing factors to the reported events.Further patient impact and/or medical assessment could not be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.This situation is captured in the risk assessment released at the time of the complaint.As a result of these findings, it was determined that the software functioned as intended; no defect of the system occurred.Based on the investigation, no containment or corrective actions are recommended at this time.

• 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
• MDR Report Key: 11851793
• MDR Text Key: 251690312
• Report Number: 3010266064-2021-00390
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROB20000 CORI ROBOTICS USA.
• Patient Outcome(s): Hospitalization; Other; Required Intervention