REAL INTELLIGENCE ROB10016Recalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 00885556757352), received between Nov 4, 2021 and Apr 13, 2026 — classified as 16 injuries, 202 malfunctions.

The most frequently reported specific device problem is “Fracture” (164 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 25 most recent of 218 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Unintended Movement

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, WHILE BURRING, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD WOULD NOT SIT FLUSH AND BURR CLEANLY. ATTEMPTED TO TAKE OFF AND PUT BACK ON, CLEAN FOR DEBRIS WITHOUT RESOLUTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865456 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, WHILE CUTTING THE DISTAL FEMUR, IT WAS NOTICED THAT THE SUCTION ATTACHMENT DETACHED FROM THE REST OF ONE (1) REAL INTELLIGENCE ROBOTIC DRILL GUARD. IT WAS HELD ON BY THE SUCTION TUBING, THEREFORE, NO FRAGMENTS FELL INTO THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881004 ↗
• MalfunctionDec 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THREE (3) REAL INTELLIGENCE ROBOTIC DRILL GUARDS WERE TRIED AND NONE OF THEM WOULD ALLOW INSERTION INTO ONE (1) REAL INTELLIGENCE POINT PROBE. THE PROBLEM WAS WITH THE REPORTED GUARDS AS THE TIPS WERE SCARRED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PROCEDURE WAS RESUMED WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816360 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687234 ↗
• MalfunctionJul 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, WHILE CUTTING, THE DRILL SUCTION TIP OF A REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE OFF. ALL PARTS WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552581 ↗
• MalfunctionJun 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, WHILE BURRING THE REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE APART. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288688 ↗
• MalfunctionMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE IN TWO PIECES. NO PIECES LEFT IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106949 ↗
• MalfunctionMar 25, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, WHILE CALIBRATING THE ROBOTIC PIECE, A REAL INTELLIGENCE ROBOTIC DRILL GUARD DID NOT ENTER ITS CORRESPONDING SPACE FOR THE CALIBRATION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO CONVENTIONAL SMITH AND NEPHEW SURGICAL INSTRUMENTATION. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692835 ↗
• MalfunctionMar 17, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHILE FINISHING BURRING OF TIBIA, THE DRILL POPPED A CONNECTION ERROR. IT WAS ABLE TO RECALIBRATE, BUT STILL REAL INTELLIGENCE ROBOTIC DRILL GUARD SPUN AND DID NOT STAY FIXED TO DRILL IN PLACE. THE DRILL GUARD HAD A NOTICEABLE DEFECT AND UPON DRILLING IT SPUN OFF, LAUNCHED INTO THE CEILING AND BACK WALK, AND LUCKILY DID NOT LAND ON THE STERILE FIELD. HAD IRRIGATION TUBING BEEN AVAILABLE THIS WOULD NOT HAVE HAPPENED. THE PROCEDURE WAS FINISHED WITH CORI AFTER THE DRILL GUARD WAS REPLACED. ABLE TO COMPLETE TIBIAL CUT WITH SAW AND CREATED SHELF. THE SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627419 ↗
• MalfunctionFeb 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, THE SUCTION PIECE ON ONE (1) REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE OFF WHILE BURRING. THE PIECE THAT BROKE OFF WAS RECOVERED AND SET ASIDE. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413237 ↗
• MalfunctionNov 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, WHEN BURRING THE DISTAL FEMUR, THE PRONG BROKE OFF OF THE REAL INTELLIGENCE ROBOTIC DRILL GUARD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733096 ↗
• MalfunctionNov 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD ATTACHMENT BROKE OFF. BOTH PIECES WERE OBTAINED. NONE OF THEM FELL INTO PATIENT'S ANATOMY. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591486 ↗
• MalfunctionMar 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA PROCEDURE, A REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE IN TWO PIECES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950853 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE BONE-PREP PHASE OF A CORI ASSISTED TKA SURGERY, WHEN BONE WAS BEING REMOVED FROM THE PROXIMAL TIBIA, THE END OF THE REAL INTELLIGENCE ROBOTIC DRILL GUARD SEPARATED FROM THE REMAINDER OF THE FUSELAGE. THE SURGEON STOPPED, IRRIGATED THE FIELD, AND VISUALLY INSPECTED THE PATIENT'S ANATOMY. NO SIGNS OF DAMAGE OR HARM WERE NOTED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703218 ↗
• MalfunctionDec 7, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD DID NOT FULLY COVERED THE RETRACTED BURR. THIS CAUSED THE PA TO TOUCH THE BURR WHEN REACHING FOR THE CORI DRILL AND CREATED A PUNCTURE IN HIS GLOVE, DISTURBING THE STERILE FIELD. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287740 ↗
• MalfunctionApr 11, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THREE (3) REAL INTELLIGENCE ROBOTIC DRILL GUARD WERE LOOSE, SLIDING OFF THE DRILL WHILE THE SURGEON WAS BURRING. THEY WERE NOT FIXATING ONTO LONG ATTACHMENT. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MINUTES, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717891 ↗
• MalfunctionJun 11, 2022Break; Break

  IT WAS REPORTED THAT, ONCE THE FEMUR WAS COMPLETED DURING A CORI ASSISTED UKA SURGERY, TWO (2) INTELLIGENCE ROBOTIC DRILL GUARDS BROKE AT THE SUCTION BARB. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED, WITH A NON SIGNIFICANT SURGICAL DELAY, USING A S+N BACK UP DEVICE. FINALLY UPON COMPLETION, KPC TEST WAS ATTEMPTED AND RI ROBOTIC DRILL ATTACHMENT AND REAL INTELLIGENCE ROBOTIC DRILL TRACKER WERE LOCKED TOGETHER BY THE REAL INTELLIGENCE ROBOTIC DRILL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670206 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING BONE REMOVAL IN A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD WAS CONTINUOUSLY SPINNING LOOSE AND EVENTUALLY THE BARB BROKE OFF. THE BARB FELL INTO THE SURGEONS FINGERS AND WAS RETRIEVED SUCCESSFULLY IMMEDIATELY. ADDITIONALLY, IT WAS OBSERVED THAT THE RI ROBOTIC DRILL ATTACHMENT HAD A DAMAGE AT THE END WHICH HOLDS THE BURR. THE WHITE PLASTIC TIP APPEARS TO HAVE WORN DOWN AND IS WARPED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICES WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655192 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE OFF, EXTERNAL TO THE PATIENT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITHOUT THE GUARD . AFTER THE CASE, THE ROBOTIC HANDPIECE AND LONG ATTACHMENT WERE JAMMED AND LOCKED ON TO EACH OTHER AND WOULD NOT COME APART, THEREFORE THE ROBOTIC TRACKING ARRAY WAS LOCKED TOO. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655149 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE, EXTERNAL TO THE PATIENT. THE PIECE FELL IN THE DRAPES. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655147 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, AS SOON AS THE SURGEON TOUCHED THE DISTAL FEMUR TO BEGIN MILLING, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD SPUN AND BROKE OFF THE SUCTION TIP ATTACHMENT. THE BROKEN PIECE ENDED UP ON THE FLOOR AND DID NOT NEED TO BE RETRIEVED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655111 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE, EXTERNAL TO THE PATIENT. THE PIECE FELL IN THE DRAPES. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655099 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, WHILE MILLING THE DISTAL FEMUR ON TKA SURGERY ASSISTED WITH CORI, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE OFF AT THE WELD THAT HOLDS THE ATTACHMENT ON. THE DEVICE BROKE OUTSIDE THE PATIENT AND THE BROKEN PIECE WAS RETRIEVED BY HAND. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655086 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING MACHINE SETUP FOR A CORI ASSISTED SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A NON-SIGNIFICANT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655073 ↗
• MalfunctionJun 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKR, THE METAL ARM OF SUCTION TUBE PORTION OF THE REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE IN THE JOINT. THE PIECE WAS RETRIEVED FROM THE WOUND BY HAND. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640292 ↗