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

Model Number ROB10013

Device Problem Unintended Movement (3026)

Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Date 06/08/2021

Event Type  Injury  

Event Description

It was reported that, when starting the burr of the distal femur in a cori-assisted tka surgery, some mild irregularities were noticed on the cut surface and the burr completely fell out of the real intelligence robotic drill.Therefore, the burr was re-inserted, and without running the burr, the distal cut previously done was refined, which turned completely red and showed they were deeper than plan on 1/2 the lateral condyle ((b)(4)).Cori system took more bone than intended on the distal femoral cut, but initially it said they weren¿t ((b)(4)).Because the bone was over resected by only a few millimeters for a small portion, it was decided to proceed with the case as normal.The burring of the rest of the distal femur was successfully completed, the 4-1 cut block was put on, and it was validated that the block positioning was perfect, and the femur cuts were completed with a saw.The defect was minimal enough to fill with cement with no concern.No significant delays (less than 30 min) were reported.

Manufacturer Narrative

Section h10: the real intelligence robotic drill used for treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.Although the product was not returned however the software files were downloaded from the system¿s console and provided for investigation.The log files do not indicate any system or software issue related to the reported complaint.The screenshots were reviewed with clinical account representatives.The case screenshots do not show the overcut, however, a picture of the femur bone removal screen was taken separately and provided for evaluation.The femur bone model is red on the distal cut of the lateral condyle, confirming the complaint.It is likely that the bur was not entirely secured upon bone removal, thus causing the overcut.It was determined that the drill was able to pass calibration with an improperly inserted bur, which is a user error.The bur is secured when the user inserts the bur until a click is heard, as instructed in the bur set up screen.Refer to the real intelligence cori for knee arthroplasty for setting up, unlocking, and loading the bur.The clinical/medical evaluation concluded: ¿based on the information provided, the clinical root cause of the reported event could not be definitively concluded.The patient impact beyond the over-resected portion of lateral condyle, cement-filled defect, and reported 0-30 minute surgical extension could not be determined.Reportedly, the bone ¿defect was minimal enough to fill with cement with no concern¿.It was reported that the procedure was successfully completed with ¿no impact on outcome¿ and ¿no harm to patient¿ with an achieved outcome within 1 of planned varus.No further medical assessment can be rendered at this time.Should a product/engineering evaluation conclusion result in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.¿ this situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no further containment or corrective actions are recommended at this time.Internal complaint reference number: (b)(4).

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, visual and functional inspections could not be performed.Although the product was not returned however the software files were downloaded from the system¿s console and provided for investigation.The log files do not indicate any system or software issue related to the reported complaint.The screenshots were reviewed with clinical account representatives.The case screenshots do not show the overcut, however, a picture of the femur bone removal screen was taken separately and provided for evaluation.The femur bone model is red on the distal cut of the lateral condyle, confirming the complaint.It is likely that the bur was not entirely secured upon bone removal, thus causing the overcut.It was determined that the drill was able to pass calibration with an improperly inserted bur, which is a user error.The bur is secured when the user inserts the bur until a click is heard, as instructed in the bur set up screen.Refer to the real intelligence cori for knee arthroplasty for setting up, unlocking, and loading the bur.The clinical/medical evaluation concluded: ¿based on the product/engineering evaluation, an improperly inserted burr/user error resulted in the pseudo-calibration, over-cut, and the burr falling out.The patient impact beyond the over-resected portion of lateral condyle, cement-filled defect, and reported 0-30 minute surgical extension could not be determined.Reportedly, the bone ¿defect was minimal enough to fill with cement with no concern¿.It was reported that the procedure was successfully completed with ¿no impact on outcome¿ and ¿no harm to patient¿ with an achieved outcome within 1 of planned varus.No further medical assessment can be rendered at this time.¿ this situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no further 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
• 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: 12043036
• MDR Text Key: 257496704
• Report Number: 3010266064-2021-00464
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 77 KG