REAL INTELLIGENCE ROB10013Recalls & reported problems

Summary

The FDA's MAUDE database contains 528 adverse event reports that list this exact device (DI 00885556757321), received between Aug 17, 2020 and May 15, 2026 — classified as 211 injuries, 317 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (258 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 13, 2023Open, Classified

   Possibility that the user is unable to resolve drill disconnection error messages.

   Z-0708-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 528 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Unintended Movement

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL STOPPED BURRING JUST AT THE START OF THE DISTAL CUT. A SECOND HANDPIECE WAS TRIED BUT IT FAILED AS WELL: WHEN THEY TRIED TO ASSEMBLE THE BURR, AFTER UNLOCKING, THE BURR WOULD PUSH THE INTERNAL MECHANISM OF THE HANDPIECE, AND IT COULDN'T CAPTURE THE BURR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184889 ↗
• MalfunctionApr 5, 2026Break; Overheating of Device; Unintended Movement; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL BEGAN TO OVERHEAT AND THEN STOPPED WORKING. THE PROCEDURE WAS CONVERTED TO A MANUAL PROCEDURE BECAUSE A BACKUP WAS NOT AVAILABLE. THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES FOR THE PATIENT. AFTER THE SURGERY THE DRILL DIAGNOSTIC COULD NOT BE PERFORMED, BECAUSE THE BUR WAS NOT ENGAGING ONTO THE HANDPIECE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787072 ↗
• MalfunctionMar 31, 2026Material Deformation; Mechanics Altered

  IT WAS REPORTED THAT, DURING CORI ASSISTED SURGERY, WHILE THE BONE CUTTING STEP, IT WAS OBSERVED THAT THE BUR HEAD WAS UNABLE TO CUT THE BONE EFFECTIVELY. AN ATTEMPT WAS MADE TO REPLACE IT WITH THE ROBOTIC DRILL EXTRA. DURING THIS PROCESS, IT WAS FOUND THAT THE ROBOTIC DRILL ATTACHMENT, BECAME STUCK. THEREFORE, THE INSTRUMENT WAS TAKEN TO THE ADMIN SYSTEM AND THE LONG ATTACHMENT ASSEMBLING FUNCTION WAS USED TO UNLOCK THE COLLET. AS THE SURGEON COULD NOT WAIT FOR FURTHER TROUBLESHOOTING, IT WAS DECIDED TO CONVERT TO A CONVENTIONAL SURGICAL TECHNIQUE TO CONTINUE THE PROCEDURE. AFTER THE INSTRUMENT WAS SUCCESSFULLY REMOVED, IT WAS OBSERVED THAT THE DISTAL END OF THE ROBOTIC DRILL WAS DAMAGED. THIS WAS CASE 5. THE CASES 1¿4 PROGRESSED NORMALLY WITHOUT ANY ISSUES. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750515 ↗
• MalfunctionMar 30, 2026Material Integrity Problem; Mechanical Jam; Noise, Audible; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TKA, THE REAL INTELLIGENCE ROBOTIC DRILL GOT STUCK AND WOULD NO LONGER WORK. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724133 ↗
• MalfunctionMar 25, 2026Break; Moisture or Humidity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED UKA SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL DID NOT DRILL. THE DEVICE WAS TESTED AFTER SURGERY, IN DIAGNOSTIC MODE AND THE MOTOR DID NOT RUN CONTINUOUSLY BUT REPEATEDLY STOPPED ROTATING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690440 ↗
• MalfunctionMar 23, 2026Mechanical Jam

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL WOULD NOT UNLOCK TO ATTACH THE BURR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (SWITCH TO MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669057 ↗
• MalfunctionMar 7, 2026Break; Connection Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED UKR SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL STOPPED DURING MILLING. THE ERROR "TIME-OUT IN SYSTEM, THE HANDPIECE HAS BEEN DEACTIVATED" OCCURRED. THE HANDPIECE WAS RECONNECTED BUT THE ERROR OCCURRED AGAIN. AFTER A SECOND ATTEMPT IT WAS RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541064 ↗
• MalfunctionMar 6, 2026Connection Problem; Unintended Movement

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED UKR SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL HAD A COMMUNICATION ERROR, IT COULD NOT LOCK THE BUR WHEN INSERTED. THERE WAS ALSO AN ERROR WHEN SELECTING A PATIENT UNABLE TO START THE PROCEDURE. THE PATCH (HANDPIECE_SETTING_CORRUPTION FIX.SH) HAS BEEN UPDATED, THE ROBOT DRILL DIAGNOSTICS HAVE BEEN PASSED, AND SO FAR THE UNIT HAS BEEN WORKING NORMALLY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536145 ↗
• MalfunctionMar 5, 2026Loose or Intermittent Connection; Connection Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN UKR SURGERY, WHEN BURRING, THE REAL INTELLIGENCE ROBOTIC DRILL KEPT STOPPING AND SLOWING DOWN. ALSO, AN ERROR MESSAGE WAS POPPING UP NONSTOP, SAYING THAT THE DRILL WAS DISCONNECTED. WHEN ATTEMPTED TO SWAP OUT THE DRILLS, GOT AN INTERNAL ERROR MESSAGE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL INSTRUMENTATION). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520138 ↗
• MalfunctionMar 3, 2026Break; Failure to Calibrate; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, AT CALIBRATION STEP, THE BURR OF ONE (1) REAL INTELLIGENCE ROBOTIC DRILL WAS NOT SPINNING. ADDITIONALLY, IT FAILED THE SET MAXIMUM SPEED TEST. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO MANUAL PROCEDURE, AS NO BACK UP WAS AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499663 ↗
• MalfunctionFeb 10, 2026Failure to Calibrate

  IT WAS REPORTED THAT DURING A TKA, THE REAL INTELLIGENCE ROBOTIC DRILL HAD AN INSTALLATION PROBLEM, WHILE THE PATIENT WAS ALREADY UNDER ANESTHESIA. IT COULDN'T BE UNLOCKED EVEN THOUGH THE MOTOR WAS MAKING NOISES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310585 ↗
• MalfunctionFeb 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TKA, WHILE MAKING THE DISTAL CUT, THE BURR OF A REAL INTELLIGENCE ROBOTIC DRILL KEPT SLIPPING OUT AND HAD TO BE RE-INSERTED. THIS OCCURRED THREE TIMES, AND EVEN AFTER THE TWO CLICKS WERE CONFIRMED. 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 24310536 ↗
• MalfunctionFeb 9, 2026Retraction Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, AT THE POINT OF STARTING BONE REMOVAL A REAL INTELLIGENCE ROBOTIC DRILL ERROR MESSAGE APPEARED ON SCREEN. DURING DIAGNOSTIC RETRACTION TIME DID NOT PASS THE TEST. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299645 ↗
• MalfunctionFeb 5, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, IT WAS NOTICED THAT THE INTERNAL CARRIAGE OF A REAL INTELLIGENCE ROBOTIC DRILL WAS COMPLETELY BLOCKED, AND IT WAS IMPOSSIBLE TO ENGAGE THE BUR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, CHANGING TO A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268496 ↗
• MalfunctionFeb 2, 2026Moisture Damage; Retraction Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL HAD AN ERROR "SYSTEM TIME OUT, ROBOTIC DEVICE IS DEACTIVATED" AND IT WAS UNABLE TO CONTINUE WITH MILLING PROCESS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241382 ↗
• MalfunctionFeb 2, 2026Connection Problem

  IT WAS REPORTED THAT DURING A TKA, THE REAL INTELLIGENCE ROBOTIC DRILL WOULDN'T CONNECT AND UNLOCK. THE PROCEDURE WAS RESUMED, AFTER A 5-MINUTE DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233161 ↗
• MalfunctionJan 14, 2026Unstable

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE BURR WOULD NOT SEAT PROPERLY INSIDE THE REAL INTELLIGENCE ROBOTIC DRILL. ON THE CUT SCREEN, THE BURR RESECTION WAS BURRING ~1 MORE THAN PLANNED. SWAPPED OUT THE LONG ATTACHMENT, BUT THE BURR STILL DID NOT SEAT PROPERLY. THEN THEY SWAPPED OUT THE HANDPIECE, AND THE PROBLEM WAS RESOLVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 24075515 ↗
• MalfunctionJan 13, 2026Positioning Failure

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKP SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL DID NOT ACCEPT THE BURR AND KEPT PUSHING IT OUT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053696 ↗
• MalfunctionJan 7, 2026Degraded; Unstable; Detachment of Device or Device Component; Mechanics Altered

  IT WAS REPORTED THAT DURING A TKA WITH THE PATIENT ALREADY UNDER ANESTHESIA, THE REAL INTELLIGENCE ROBOTIC DRILL MANAGE TO CALIBRATE BUT FAILED DURING BURRING, EVEN AFTER TROUBLESHOOTING. IT COULDN'T EVEN GRAB THE BUR CORRECTLY AND IT SUNK INTO THE DRILL. 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 23995515 ↗
• MalfunctionDec 29, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, A SILVER TRACKER ARRAY WOULD GET STUCK ON ONE (1) REAL INTELLIGENCE ROBOTIC DRILL AND NOT ROTATE, THEN THE ARRAY WAS DIFFICULT TO REMOVE. A NEW TRACKER WAS TRIED WITH THE SAME REPORTED DRILL AND ENCOUNTERED THE SAME PROBLEM. THE PROCEDURE WAS PERFORMED, 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 23919158 ↗
• MalfunctionDec 26, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE BURR WOULD NOT CLICK IN THE REAL INTELLIGENCE ROBOTIC DRILL. AN ERROR WAS RECEIVED THAT BURR WAS NOT FULLY SEATED, THEN, IT WAS NOT OPERATED WITH THIS HANDPIECE. AFTER THE OR, CHECKED THE HANDPIECE, AND IT COULD NOT RUN ANY TESTS. ALSO, THE RI ROBOTIC DRILL ATTACHMENT COULD NOT BE TAKEN OFF ANYMORE AND WAS STUCK ON THE HANDPIECE. 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 23900684 ↗
• MalfunctionDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A CORI ASSISTED SURGERY, THE SCREEN SHOWED IT WAS UNABLE TO THE CONTINUE WITH THE NEXT STEP. DISCONNECTED AND RECONNECTED THE CABLE, BUT IT STILL UNABLE. THEN REPLACED THE REAL INTELLIGENCE ROBOTIC DRILL´S CABLE, WITH NO RESULT. ALSO, THE RI ROBOTIC DRILL ATTACHMENT WAS MALFUNCTIONING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871354 ↗
• MalfunctionDec 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL FAILED TO WORK ON TEST SPIN, A NEW (1) REAL INTELLIGENCE ROBOTIC DRILL WAS TRIED AND DID NOT WORK EITHER. HAD TO RESTART THE DRILLS TO WORK. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862884 ↗
• MalfunctionDec 16, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT, DURING A BILATERAL REAL INTELLIGENCE CORI TKA SURGERY, A REAL INTELLIGENCE ROBOTIC DRILL REGISTERED PROPERLY. HOWEVER, WHEN THEY ATTEMPTED TO BURR THE DISTAL FEMUR CUT, THE BURR WOULD NOT RETRACT AS FAR AS NORMAL (APPROX. 50% AS NORMAL). AFTER THE CASES, THE HANDPIECE PASSED ALL TESTS. PROCEDURE WAS PERFORMED, USING TIBIAL CUTTING BLOCK TO DO THE DISTAL CUT. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816104 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED UKR SURGERY, WHEN CUTTING THE FEMUR AND WENT TO THE TIBIA AN FINALIZE THE FEMUR IN THE POSTERIOR CONDYLE, THE BURR RESECTED MORE BONE THAT WAS SUPPOSED TO CUT. STOPPED RESECTION AND MADE AN EXERT WITH CEMENT TO COMPENSATE THE EXTRA RESECTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER ISSUES REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 23794853 ↗