REAL INTELLIGENCE ROB10015Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00885556757345), received between Aug 15, 2020 and Apr 1, 2026 — classified as 31 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (45 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 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, THE BURR WAS INSERTED PROPERLY INTO THE RI ROBOTIC DRILL ATTACHMENT AND WAS ABLE TO SUCCESSFULLY CALIBRATE AND RETRACT. HOWEVER, WHEN GOING TO DISTAL CUT, THE BURR DISENGAGED THE HANDPIECE AND FELL OUT ONTO THE STERILE FIELD. WHEN THE BURR WAS REINSERTED AND RECALIBRATED, IT WAS SITTING UP ~2MM. THE CASE WAS COMPLETED AND THE DRILL WAS TESTED AND IT PASSED THE KPC TEST. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752445 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT DURING A TKA, THE SILVER AND BLACK COLLET OF A REAL INTELLIGENCE ROBOTIC DRILL BECAME DISENGAGED AND GOT STUCK INSIDE THE ATTACHMENT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849658 ↗
• MalfunctionDec 9, 2025Unstable; Unstable

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE BURR WOULD NOT SEAT INSIDE OF ONE (1) RI ROBOTIC DRILL ATTACHMENT, THEREFORE CONTINUED TO FAIL CALIBRATION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760931 ↗
• MalfunctionOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, THE WHITE RING PART INSIDE OF THE RI ROBOTIC DRILL ATTACHMENT WAS DISLODGED, LEAVING IT DAMAGED AND UNUSABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436893 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A CORI TKA SURGERY, IT WAS NOTICED THAT THE RUBBER TIP OF ONE (1) RI ROBOTIC DRILL ATTACHMENT HAD COME OFF. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. SINCE INCIDENT OCCURRED AFTER PROCEDURE; PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984516 ↗
• MalfunctionJul 31, 2025Unstable; Unstable

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, ONE (1) RI ROBOTIC DRILL ATTACHMENT WAS "LOOSE" ON THE DRILL. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681350 ↗
• MalfunctionApr 30, 2025Positioning Failure; Mechanical Jam; Positioning Failure; Mechanical Jam

  IT WAS REPORTED THAT, DURING SET UP/INSPECTION FOR CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL WOULD NOT ACCEPT TWO (2) RI ROBOTIC DRILL ATTACHMENTS, IT WAS UNSUCCESSFUL. IT WAS ABLE TO GET A THIRD ATTACHMENT ON, WITH SOME FORCE; HOWEVER, AFTER DOING IT, IT BECAME STUCK ON THE DRILL AND NEEDED TO GO INTO KPC TEST IN ORDER TO REMOVE IT. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE: THE SURGEON CANCELED CORI AND USED VISIONAIRE INSTEAD, AS ORIGINALLY SCHEDULE. IT WAS LATER CONVERTED INTO A CORI, THEN THE CUTTING BLOCKS HAD ALREADY BEEN MANUFACTURED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940233 ↗
• MalfunctionFeb 12, 2025Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT, DURING DISTAL BURRING IN A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, ONE (1) RI ROBOTIC DRILL ATTACHMENT FELL OFF THE CARRIAGE. THE ENTIRE COLLET FELL APART AND BECAME DISASSEMBLED FROM ONE (1) REAL INTELLIGENCE ROBOTIC DRILL. SOME OF THE DRILL COLLET BECAME PERMANENTLY LODGED INTO THE DRILL ATTACHMENT. THE PROCEDURE WAS RESUMED AFTER A NON-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 21365183 ↗
• MalfunctionNov 19, 2024Break; Material Discolored; Material Deformation; Break; Material Discolored; Material Deformation

  IT WAS REPORTED THAT, DURING A CORI-ASSISTED TKA SURGERY, THE PLASTIC TIP OF ONE (1) RI ROBOTIC DRILL ATTACHMENT BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO PIECES HAD FALLEN INTO THE PATIENT. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724048 ↗
• MalfunctionSep 9, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY ONE (1) RI ROBOTIC DRILL ATTACHMENT WAS NOT STAYING DRILL CORRECTLY; SHIFTING WHILE CUTTING BONE. 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 20175506 ↗
• MalfunctionAug 31, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY ONE (1) RI ROBOTIC DRILL ATTACHMENT LOCKED/STUCK ON HANDPIECE, THEREFORE THE DRILL TRACKER IS ALSO STUCK ON THE HANDPIECE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY BY USED THE SAW FOR THE DISTAL CUT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20114206 ↗
• MalfunctionJul 30, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE RI ROBOTIC DRILL ATTACHMENT HAS ALMOST BEEN LOCKED IN THE DRILL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19868862 ↗
• MalfunctionJul 17, 2024Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, A REAL INTELLIGENCE ROBOTIC DRILL WOULD NOT BURR THE GREEN OF THE BONE AND THE PEGS FOR THE DISTAL FEMUR. IT WAS ALSO BURRED INCORRECTLY AND NOT FLAT ON THE TIBIA. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767925 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE SILICONE PACKING, WHICH PREVENT SUBSTANCES ENTERING INTO THE RI ROBOTIC DRILL ATTACHMENT, HAS BEEN REMOVED FROM THE DEVICE. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454719 ↗
• MalfunctionMay 31, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A CORI ASSISTED UKR SURGERY, THE DRILL ATTACHMENT GOT LOCKED/STUCK ON HANDPIECE, THEREFORE, THE DRILL TRACKER ALSO GOT STUCK. THE PROCEDURE WAS PERFORMED, AFTER A NO DELAY, NAVIGATING WITH CORI BUT USING THE SAW FOR THE DISTAL CUT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19440590 ↗
• InjuryMay 14, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE DRILL ATTACHMENT CAUSED THE BURR TO FALL OUT DURING DISTAL BURR STAGE TODAY, WHICH CAUSED A REMOVAL OF LITTLE EXCESS BONE WHEN BURR FELL OUT OF DRILL. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Laceration(s)

  MAUDE report 19310612 ↗
• MalfunctionMay 13, 2024Unstable; Unstable

  IT WAS REPORTED THAT, DURING BURRING OF THE TIBIA, THE BUR FELL OUT OF THE DRILL. IT IS UNKNOWN IF BROKEN PIECES FELL INTO THE PATIENT. WHEN ATTEMPTING TO RECALIBRATE THE RI ROBOTIC DRILL ATTACHMENT WOULD NOT ALLOW THE BUR TO FULLY SEAT. 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 19305679 ↗
• MalfunctionFeb 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE RI ROBOTIC DRILL ATTACHMENT WAS BROKEN. AS THIS WAS NOTICED UPON PREVENTATIVE MAINTENANCE ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669415 ↗
• MalfunctionFeb 4, 2024Mechanical Jam; Noise, Audible; Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THE REAL INTELLIGENCE ROBOTIC DRILL SUDDENLY MADE LOUD SQUEAKING NOISES AND THEN BLOCKED COMPLETELY ALONG WITH THE RI ROBOTIC DRILL ATTACHMENT AND REAL INTELLIGENCE ROBOTIC DRILL TRACKER. IT CAN NO LONGER BE DISMANTLED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, CHANGING TO MANUAL PROCEDURE. PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637588 ↗
• MalfunctionJan 23, 2024Connection Problem; Detachment of Device or Device Component; Mechanical Jam; Connection Problem; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHEN BURRING THE DISTAL FEMUR, THE BUR MADE A GRINDING NOISE AND THE SCREEN SHOWED ¿INTERNAL SYSTEM ERROR¿. THE CASE HAD TO BE SWITCHED TO MANUAL FROM THAT POINT ON, AFTER A NON-SIGNIFICANT DELAY, AS THE HANDPIECE COULD NOT BE RECOVERED. AFTER THE CASE, THE BUR WAS UNABLE TO BE REMOVED, SO THE RI ROBOTIC DRILL ATTACHMENT AND REAL INTELLIGENCE ROBOTIC DRILL TRACKER ARE STUCK ON THE REAL INTELLIGENCE ROBOTIC DRILL AS WELL. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563392 ↗
• MalfunctionJan 2, 2024Connection Problem; Mechanical Jam; Unintended Application Program Shut Down; Connection Problem; Mechanical Jam; Unintended Application Program Shut Down

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, THE BUR STOPPED WORKING AND THE REAL INTELLIGENCE ROBOTIC DRILL SHOWED A DISCONNECT ERROR DURING DISTAL FEMUR RESECTION; THEN, AN INTERNAL ERROR MESSAGE CAME UP WHEN TRYING TO RESTART. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY SWITCHING TO MANUAL PROCEDURE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE. AFTER THE PROCEDURE, IT WAS NOTICED THAT IT WAS NOT POSSIBLE TO REMOVE THE BUR OR THE RI ROBOTIC DRILL ATTACHMENT FROM THE ROBOTIC DRILL, NOT EVEN WITH THE DRILL DIAGNOSTIC FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18429930 ↗
• MalfunctionDec 21, 2023Connection Problem; Mechanical Jam; Connection Problem; Mechanical Jam

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, A "SYSTEM TIME OUT" ERROR WAS DISPLAYED. AFTER THIS NOTIFICATION THE REAL INTELLIGENCE ROBOTIC DRILL DID NOT FUNCTION ANY MORE. THEY WERE ABLE TO TAKE THE BURR OUT THE REAL INTELLIGENCE ROBOTIC DRILL BUT COULD NOT UNLOCK THE RI ROBOTIC DRILL ATTACHMENT NOR THE REAL INTELLIGENCE ROBOTIC DRILL TRACKER. THEY ALSO TRIED TO UNLOCK THEM IN THE ADMIN BUT DID NOT WORK. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378320 ↗
• InjuryNov 27, 2023Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, WHILE BURRING, THE REAL INTELLIGENCE ROBOTIC DRILL WAS DISCONNECTED DUE TO AN ERROR CONNECTION AND IT WAS NOTICED THAT THE RI ROBOTIC DRILL ATTACHMENT WAS STUCK WITH THE HANDPIECE. IT WAS TRIED TO DISASSEMBLE IT WITH THE HANDPIECE DIAGNOSTICS BUT IT WAS NOT POSSIBLE. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY BY MANUAL PROCEDURE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212853 ↗
• InjuryNov 21, 2023Detachment of Device or Device Component; Mechanical Jam; Mechanics Altered; Physical Resistance/Sticking; Detachment of Device or Device Component; Mechanical Jam; Mechanics Altered; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHILE BURRING THE DISTAL CUT IN THE MIDDLE OF THE CASE, THE REAL INTELLIGENCE ROBOTIC DRILL HAD A MOTOR FAILURE AND THE BURR STOPPED SPINNING. THE REP RAN THROUGH ALL THE TROUBLESHOOTING TACTICS AND THE HANDPIECE WOULD NOT RECALIBRATE. ALSO, WAS UNABLE TO REMOVE THE RI ROBOTIC DRILL ATTACHMENT ALONG WITH REAL INTELLIGENCE ROBOTIC DRILL TRACKER. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183073 ↗
• InjuryJul 14, 2023Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, THE MILLING CUTTER COULD NOT BE LOCKED IN THE REAL INTELLIGENCE ROBOTIC DRILL; AFTERWARDS, THE DRILL WITH THE TRACKER AND RI ROBOTIC DRILL ATTACHMENT COULD NOT BE DISASSEMBLED USING THE KPC TESTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAYS, BY SWITCHING THE SURGICAL TECHNIQUE INTO A MANUAL PROCEDURE. NO PATIENT INJURY WAS REPORTED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326115 ↗