REAL INTELLIGENCE ROB10011Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885556757307), received between Jan 26, 2021 and Dec 24, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA, TWO (2) PINS OF A RI BONE PINS 4 MM X 152 MM QTY: 2 WERE USED TO DRILL INTO FEMUR WITHOUT USING DRILL GUIDE OR CLAMPS. CLAMP WAS PUT ON SCREWS AND TIGHTENED. AFTER THAT, HIP REGISTRATION FAILED THREE TIMES WITH FULL REBOOT AND NEW CASE CREATION. LAST TROUBLESHOOTING STEP WAS CHANGING THE ARRAYS. WHEN FEMUR ARRAY CLAMP WAS LOOSENED THE SCREWS WERE BENT. 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 23889001 ↗
• MalfunctionNov 26, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT, AFTER THE PINS WERE TAKEN OUT, DURING A CORI ASSISTED TKA, IT WAS NOTICED THAT THE RI BONE PINS 4 MM X 152 MM QTY: 2 WERE CHIPPED. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784776 ↗
• InjuryAug 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHEN INSERTING A RI BONE PINS 4 MM X 152 MM INTO THE FEMUR OF THE PATIENT, THE PIN SNAPPED. THE ENTIRE THREADED SEGMENT OF THE PIN REMAINED IN THE PATIENT. THE SURGEON DID NOT ATTEMPT TO RETRIEVE THE SEGMENT AND REMAINS IN-SITU POST PROCEDURE. THE SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN. IT IS ALSO UNKNOWN IF A REVISION SURGERY HAS BEEN SCHEDULED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20086575 ↗
• MalfunctionJan 3, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT IT WAS NOTICED THAT THERE HAVE BEEN AN INCIDENT OF SIX (6) BENT RI BONE PINS 4 MM X 152 MM QTY: 2. THEY ARE NO LONGER USEABLE IN CORI CASES AND MUST BE REPLACED. THESE PINS WERE COLLECTED OVER A SPAN OF A COUPLE MONTHS AND WERE NOTICED BEFORE AND AFTER CASES AS UNUSABLE. IF THE CASE WAS OPEN AND THE PINS WERE BENT, THEY WERE SWAPPED WITH UNDAMAGED PINS. AS NO CASE WAS INVOLVED, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435958 ↗
• MalfunctionOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE END OF A RI BONE PINS 4 MM X 152 MM QTY: 2 BROKE OFF INTO THE SPEED PIN DRIVER. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034335 ↗
• MalfunctionJun 16, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, FOUR(4) RI RI BONE PINS 4 MM X 152 MM WERE BENT AND NOT ENTERING SMOOTHLY INTO THE BONE, THE SURGEON HAD TO FORCE THEM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH S+N BACK-UP DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14720997 ↗
• MalfunctionJun 8, 2022Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE RI BONE PINS 4 MM X 152 MM WAS BLUNT AND WAS NOT GETTING INTO THE BONE EASILY, THE SURGEON NEEDED TO FORCE IT AND IT BENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICES WITHOUT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640275 ↗
• MalfunctionJun 6, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SET UP OF CORI ASSISTED UKR, IT WAS NOTICED THAT ONE RI BONE PINE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611334 ↗
• MalfunctionMay 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE RI BONE PINS 4 MM X 152 MM BENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538345 ↗
• MalfunctionMay 4, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE STERILE PROCESSING TEAM NOTED SMALL SCRATCHES ON THE THREADS OF ELEVEN RI BONE PINS 4 MM X 152 MM WHILE RE-PROCESSING THE TRAYS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279603 ↗
• MalfunctionApr 8, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING SET UP OF CORI ASSISTED SURGERY, IT WAS NOTICED THAT THE THREADS ON A RI BONE PIN WERE DAMAGED. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14051337 ↗
• MalfunctionMar 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, WHEN THE SURGEON WAS INSERTING THE RI BONE PIN 4 MM X 152 MM INTO THE BONE, IT SEVERELY BENT AND WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED DUE TO THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635767 ↗
• MalfunctionJan 19, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING BONE PIN REMOVAL IN A CORI ASSISTED TKA SURGERY, ONE RI BONE PINS 4 MM X 152 MM BENT WHILE REMOVING IT FROM THE PATIENT. THE PIN WAS STILL IN ONE PIECE AND DID NOT BROKE OFF. THIS EVENT DID NOT AFFECTED THE CASE NOR WAS THERE ANY DAMAGE TO THE PATIENT. NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13294638 ↗
• MalfunctionNov 24, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE RI BONE PINS 4 MM X 127 MM QTY: 4 AND THE RI BONE PINS 4 MM X 152 MM QTY: 2 WERE BENT. IT IS UNKNOWN WHEN THIS WAS NOTICED AND IF THERE WAS A PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870942 ↗
• MalfunctionNov 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER A CORI CASE AND WHILE IN SPD, IT WAS NOTICED THAT ONE RI BONE PINS 4 MM X 152 MM QTY: 2 WAS BENT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852819 ↗
• MalfunctionSep 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED TKA SURGERY, ONE PIN OF RI BONE PINS 4 MM X 152 MM QTY: 2 WAS BENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509568 ↗
• MalfunctionJun 30, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT UPON OPENING THE TRAY, IT WAS FOUND THAT ONE OF THE RI BONE PINS 4 MM X 152 MM QTY: 2 HAD BEEN DAMAGED. THE BONE PIN IS DEFORMED AND HAS DAMAGED THREADS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096448 ↗
• MalfunctionMay 13, 2021Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT, DURING A CORI-ASSISTED SURGERY, THE BUR CONTACTED THE RI BONE PIN 4 MM X 152 MM, THEREFORE, THE PIN WAS DAMAGED (DAMAGED THREADS). THERE WAS NO DELAY AND NO PATIENT WAS HARMED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823004 ↗
• InjuryMar 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING CORI TKA PROCEDURE WHEN REMOVING 1 OF THE 2 CORI BONE PINS FROM THE FEMUR, THE SURGEON NOTICED THAT THE TIP OF THE BONE PIN HAD BROKEN OFF. THE PATIENT WAS NOT HARMED. THE TIP OF BONE PIN WAS DISPOSED OF IN SHARPS. NO DELAY OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483517 ↗
• MalfunctionJan 26, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A CORI TKA PROCEDURE, THERE WAS A BENT BONE PIN 4.0 MM 152 MM. THERE WAS A DELAY OF FEWER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229656 ↗