REAL INTELLIGENCE ROB10036Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556757512), received between Oct 24, 2022 and Apr 29, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Break; Break

  IT WAS REPORT THAT. DURING A CORI ASSISTED SURGERY. THE REAL INTELLIGENCE 6 MM CYLINDRICAL BUR WAS NOTICED TO BE BROKEN INSIDE A REAL INTELLIGENCE ROBOTIC DRILL DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED TO REMOVE THE BONE ADDITIONALLY BY SURGICAL INSTRUMENTS, WITHOUT ANY DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210036 ↗
• MalfunctionJan 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED UKA SURGERY, THE SURGEON REMOVED THE PATIENT BONE USING THE REAL INTELLIGENCE 6 MM CYLINDRICAL BUR, BUT THE BUR WAR BROKE INSIDE THE REAL INTELLIGENCE ROBOTIC DRILL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK-UP DRILL. NO PATIENT INJURIES AND COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511189 ↗
• MalfunctionDec 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED UKR, WHILE REMOVING THE PATIENT'S BONE USING EXPOSURE MODE WITH A REAL INTELLIGENCE 6 MM CYLINDRICAL BUR, THE PATIENT'S BONE SUDDENLY WOULD NOT BE REMOVED; THE DRILL WAS CHECKED AND THE BUR WAS BROKEN INSIDE THE DRILL. NO PIECES OF THE DEVICE FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A BACKUP ROBOTIC DRILL. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370327 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHILE CUTTING THE BONE, THE BURR 6 MM WAS BROKEN. TO CONTINUE THE CASE THEY REBOOTED THE CONTROL UNIT AND USED A BACK-UP HANDPIECE, STARTED AGAIN TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322732 ↗
• InjuryOct 26, 2023Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  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.

  Patient problems: Laceration(s)

  MAUDE report 18009518 ↗
• MalfunctionJul 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHILE TIBIAL BURR, THE REAL INTELLIGENCE 6 MM CYLINDRICAL BUR STOPPED SPINNING AND GOT FREE FROM THE REAL INTELLIGENCE ROBOTIC DRILL. THE FEMUR CUT WAS FINE. THE AFFECTED DRILL DID NOT ACCEPT A NEW BURR, AND VISUALLY THE INITIAL BURR END TIP CONNECTION FRACTURED GOT STUCK INTO IT. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368150 ↗
• MalfunctionMay 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHEN BURRING THE REAL INTELLIGENCE 6 MM CYLINDRICAL BUR FELL OUT. THE BUR BROKE AT END. A SMALL TIP WAS STUCK IN DRILL COLLET, RETRIEVE AND REMOVED FROM FIELD. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986589 ↗
• MalfunctionOct 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, A REAL INTELLIGENCE 6 MM CYLINDRICAL BUR BROKE OFF AT THE CONNECTION. THE PIECE OF THE BROKEN BUR WAS STUCK INTO THE HANDPIECE. NO PIECE FELL INTO THE PATIENT. SURGERY WAS FINISHED AFTER A NON-SIGNIFICAND DELAY WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15664165 ↗