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

Model Number ROB10013

Device Problems Unstable (1667); Physical Resistance/Sticking (4012)

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

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that during a cori assisted ukr surgery while burring the femur in exposure mode, bur overcut bone by 6-8mm.They proceeded to reassembled same bur within drill after unlocking and locking attachment and continue without issue.They suspect the edge of bur caught on hard bone and was dislodged from the assemble (case- (b)(4) and case- (b)(4) ).The surgeon filled in defect with cement.The procedure was completed, with a non-significant delay, using the same device.The post-op rom and alignment and sizing were as planned.After surgery, they were unable to disassemble ri robotic drill attachment from the drill.They went into drill diagnostics, unlocked collet, and were able to remove the attachment (case- (b)(4) and case- (b)(4)).

Manufacturer Narrative

H3, h6.The real intelligence robotic drill, part number rob10013, used for treatment was not returned for evaluation.An image was provided.A relationship between the reported event and the device was established.The clinical/medical investigation concluded that user technique cannot be ruled out as a potential contributing factor.The cori user manual warns when the drill movement exceeds recommended velocity, may lead to overcutting (500230 revd).Although the surgeon was reportedly ¿satisfied in the end¿outcome was fine,¿ the ¿surgeon stated just used more cement¿ to fill the defect.¿ it is unknown if the patient will be at risk for possible early intervention or revision due to the use of ¿more cement¿ to fill the defect.However, it was reported that the¿ post-op rom and alignment and sizing were as planned.The patient impact beyond the reported burr overcut (6-8mm), surgical delay, modified surgical technique with use of ¿more cement to fill defect¿ cannot be determined.The reported problem was confirmed with a visual inspection.The image provided confirms the overcut.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.Refer to the real intelligence cori for knee arthroplasty user manual, section assembling the robotic drill 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 within the product risk profile.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The most likely cause of this event is associated with the cut technique.Based on the investigation, the need for a corrective action is not recommended or required at this time.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.H11: corrected information in h6 (health effect - impact code).

• 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: 12975688
• MDR Text Key: 282051077
• Report Number: 3010266064-2021-00863
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 12/07/2022

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?: No
• 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
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/07/2022
• 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: A
• Patient Sequence Number: 1