MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 6 MM CYLINDRICAL BUR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB10036

Device Problems Material Deformation (2976); Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 09/29/2023

Event Type  Injury  

Event Description

It was reported that, during a cori-assisted tka, the target bone was over-cut and bone removal screen showed the bone surface in red when removing the bone.The procedure was completed by filling with bone cement the over-cut.There was a twenty-minute procedural delay.They did not feel satisfied with surgery¿s outcome.In addition, after the procedure, the tip of the real intelligence 6 mm cylindrical bur was protruded about 1-2 mm from the drill guard.It was found that the connection part of the burr which was used in procedure, was deformed.Surgery was performed, doing a medical intervention.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the real intelligence 6 mm cylindrical bur, part number rob10036, lot 1103261, used for treatment was returned for evaluation.Although the burr had a physical defect, it did not affect the functionality of the drill.Nothing was identified visually that contributed to the reported problem.The local product quality team was informed of this defect.A functional evaluation was performed, and the reported problem was not confirmed.The burr was able to be locked in with 2 clicks, and when validating the burr at 0mm, the burr sat flush with the drill guard.The burr¿s validation at several specified exposures were all accurate.A kpc was completed and passed.A test case was completed without issue.The drill burred into delrin, and no failures occurred.The burr performed appropriately and did not come loose from the drill.The drill was taken apart for further investigation.The drill¿s exposure motor was tested and passed.The drill¿s wiring was tested and passed.The drill is functioning as intended.An engineering review was completed.The exposure motor encoder was tested and found to be responsive.A screenshot review was performed.The reported problem was confirmed.The screenshots showed an overcut over the bone.It is shown that procedurally, the surgeon followed the steps of the case progression correctly.This, however, does not account for inserting the burr, as that cannot be seen through screenshots.The all-over red that was shown on the bone model indicates that the burr was protruded past the drill guard the entire time and was not an anomaly of the drill.The provided logfiles were reviewed with our software team, and although the navio logs were present, a thorough analysis could not be completed without the xsession log files, which were requested multiple times and have not been received.If the xsession log files are received, a proper software investigation can be performed.The xsession log files can be retrieved from the admin screen, as compared to the navio logs which are retrieved from the case information screen.The most likely cause of the reported complaint may have been associated with the user not locking the burr in appropriately.A review of manufacturing records indicates the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d), section setting up the bur for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Based on the documentation provided, no clinical factors have been identified which would have contributed to the reported event and a mechanical or user error cannot be definitively ruled out.The patient impact included the unplanned over-burring which required ¿more than usual¿ bone cement to fill.This cement fill is a potential impact as cement is used for bonding not filling voids.It is unknown how much cement was used and if a thicker cement mantel would affect the potential loosening of the tibial component in the future.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

Manufacturer Narrative

H3, h6: the real intelligence 6 mm cylindrical bur, part number rob10036, lot 1103261, used for treatment was returned for evaluation.Although the burr had a physical defect, it did not affect the functionality of the drill.Nothing was identified visually that contributed to the reported problem.The local product quality team was informed of this defect.A functional evaluation was performed, and the reported problem was not confirmed.The burr was able to be locked in with 2 clicks, and when validating the burr at 0mm, the burr sat flush with the drill guard.The burr¿s validation at several specified exposures were all accurate.A kpc was completed and passed.A test case was completed without issue.The drill burred into delrin, and no failures occurred.The burr performed appropriately and did not come loose from the drill.The drill was taken apart for further investigation.The drill¿s exposure motor was tested and passed.The drill¿s wiring was tested and passed.The drill is functioning as intended.An engineering review was completed.The exposure motor encoder was tested and found to be responsive.A screenshot review was performed.The reported problem was confirmed.The screenshots showed an overcut over the bone.It is shown that procedurally, the surgeon followed the steps of the case progression correctly.This, however, does not account for inserting the burr, as that cannot be seen through screenshots.The all-over red that was shown on the bone model indicates that the burr was protruded past the drill guard the entire time and was not an anomaly of the drill.The provided logfiles were reviewed with our software team, and although the navio logs were present, a thorough analysis could not be completed without the xsession log files, which were incomplete.Although the xsession logs were attempted to be downloaded, the full extraction of the xsession log files was not complete.If the xsession log files are received, a proper software investigation can be performed.The xsession log files can be retrieved from the admin screen, as compared to the navio logs which are retrieved from the case information screen.The extraction needs to reach 100% before the usb can be removed.The most likely cause of the reported complaint may have been associated with the user not locking the burr in appropriately.A review of manufacturing records indicates the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d), section setting up the bur for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Based on the documentation provided, no clinical factors have been identified which would have contributed to the reported event and a mechanical or user error cannot be definitively ruled out.The patient impact included the unplanned over-burring which required ¿more than usual¿ bone cement to fill.This cement fill is a potential impact as cement is used for bonding not filling voids.It is unknown how much cement was used and if a thicker cement mantel would affect the potential loosening of the tibial component in the future.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

Manufacturer Narrative

H6: the real intelligence 6 mm cylindrical bur, part number rob10036, lot 1103261, used for treatment was returned for evaluation.Although the burr had a physical defect, it did not affect the functionality of the drill.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was not confirmed.The burr was able to be locked in with 2 clicks, and when validating the burr at 0mm, the burr sat flush with the drill guard.The burr¿s validation at several specified exposures were all accurate.A kpc was completed and passed.A test case was completed without issue.The drill burred into delrin, and no failures occurred.The burr performed appropriately and did not come loose from the drill.The drill was taken apart for further investigation.The drill¿s exposure motor was tested and passed.The drill¿s wiring was tested and passed.The drill is functioning as intended.An engineering review was completed.The exposure motor encoder was tested and found to be responsive.A screenshot review was performed.The reported problem was confirmed.The screenshots showed an overcut over the bone.It is shown that procedurally, the surgeon followed the steps of the case progression correctly.This, however, does not account for inserting the burr, as that cannot be seen through screenshots.The all-over red that was shown on the bone model indicates that the burr was protruded past the drill guard the entire time and was not an anomaly of the drill.The provided system logfiles were reviewed with our software team, it was determined that there was no evidence of a system or software issue.The analysis of the logfiles indicates instances of femur overcutting occurring within 2-3 minutes, and tibia overcutting within 6-7 minutes.The z-index of the burr showed a high value which contributes to the burr not being locked in properly.If the user would have tugged on the burr when instructed, the burr would not have stayed in place.No tool homing errors were seen, the system was functioning as intended.The most likely cause of the reported complaint is due to the user not properly loading the burr.A review of manufacturing records indicates the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the lot or part number and scope of this complaint, and no further escalation action is required.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d), section setting up the bur for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Based on the documentation provided, no clinical factors have been identified which would have contributed to the reported event and a mechanical or user error cannot be definitively ruled out.The patient impact included the unplanned over-burring which required ¿more than usual¿ bone cement to fill.This cement fill is a potential impact as cement is used for bonding not filling voids.It is unknown how much cement was used and if a thicker cement mantel would affect the potential loosening of the tibial component in the future.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE 6 MM CYLINDRICAL BUR
• 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: 18009518
• MDR Text Key: 326555418
• Report Number: 3010266064-2023-00181
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10036
• Device Lot Number: 1103261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/28/2023; 12/21/2023; 02/05/2024
• Supplement Dates FDA Received: 11/29/2023; 12/26/2023; 02/06/2024
• 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: A
• Patient Sequence Number: 1
• Treatment: PN: ROB10013 / SN: (B)(6).; PN: ROB10024 / SN: (B)(6).