REAL INTELLIGENCE ROB10010Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556757277), received between Oct 9, 2020 and Jun 16, 2022 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, TWO (2) RI BONE PINS 4 MM X 127 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 14720691 ↗
• MalfunctionJun 9, 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 127 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 14640428 ↗
• MalfunctionApr 8, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, SIX (6) RI BONE PINS 4 MM X 127 MM WERE BENT. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED DUE TO THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14051318 ↗
• MalfunctionMar 29, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED SURGERY, ONE RI BONE PINS 4 MM X 127 MM 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 13935431 ↗
• MalfunctionJan 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, SIX RI BONE PINS 4 MM X 127 MM WERE BENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY, USING THE SAME DEVICES. THE PATIENT WAS NOT HARMED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214762 ↗
• MalfunctionJan 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, SIX RI BONE PINS 4 MM X 127 MM WERE BENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY, USING THE SAME DEVICES. THE PATIENT WAS NOT HARMED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214612 ↗
• MalfunctionDec 29, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE SURGEON ATTEMPTED TO DRILL THE RI BONE PINS 4 MM X 127 MM INTO THE TIBIA AND WHILE SLIDING THROUGH THE TISSUE PROTECTOR, HE NOTED THAT THE RI BONE PINS 4 MM X 127 MM WAS SLIGHTLY BENT AT THE TIP. 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 13113027 ↗
• MalfunctionDec 29, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AT THE END OF A CORI ASSISTED TKA SURGERY, WHILE REMOVING THE RI BONE PINS 4 MM X 127 MM FROM THE TIBIA, THE MORE PROXIMAL PIN WAS BENT TOWN THE END OF THE PIN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110616 ↗
• MalfunctionDec 17, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED TKA SURGERY, TWO RI BONE PINS 4 MM X 127 MM QTY: 4 WERE 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 13031349 ↗
• MalfunctionDec 15, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SET UP FOR A CORI ASSISTED TKA SURGERY, TWO RI BONE PINS 4 MM X 127 MM QTY: 4 WERE 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 13014378 ↗
• 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 12871069 ↗
• MalfunctionNov 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER A CORI CASE AND WHILE IN SPD, IT WAS NOTICED THAT RI BONE PINS 4 MM X 127 MM QTY: 4 WAS BENT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852794 ↗
• MalfunctionNov 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER A CORI CASE AND WHILE IN SPD, IT WAS NOTICED THAT A RI BONE PINS 4 MM X 127 MM (QTY: 4) WAS BENT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852618 ↗
• MalfunctionJun 17, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SET UP FOR A CORI-ASSISTED UKR SURGERY, IT WAS NOTICED THAT THE RI BONE PINS 4 MM X 127 MM WAS SIGNIFICANTLY BENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021804 ↗
• InjuryMar 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT BEFORE STARTING THE CASE, THEY TIGHTENED THE TRACKER CLAMP DOWN WITH THE CORRECT TOOL. HOWEVER, DURING A CORI TKA XR PROCEDURE, THE TRACKER CLAMP SLID ON THE TIBIAL BONE PINS WHEN CUTTING THE FEMUR. IT IS UNKNOWN WHICH OF THE TWO WERE FAULTY. THEY CHANGED TO MANUAL INSTRUMENTATION FOR TIBIA CUTTING. THERE WAS A DELAY GREATER THAN 30 MIN. THE PATIENT CARE WAS NOT COMPROMISED. NO OTHER COMPLICATIONS WERE REPORTED. SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515701 ↗
• MalfunctionFeb 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER THE SURGEON HAD COMPLETED ALL HIS CUTS AND WAS READY TO CEMENT THE FINAL IMPLANT DURING A CORI PROCEDURE, HE WENT TO REMOVE THE CORI TRACKERS AND BONE PINS. ONE BONE PIN BENT WHEN HE WAS EXTRACTING IT FROM THE PATIENT. THERE WAS NO IMPACT TO THE PATIENT AND THE REST OF THE SURGERY CONTINUED AS NORMAL WITHOUT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335677 ↗
• MalfunctionOct 9, 2020Break; Break

  IT WAS REPORTED THAT AFTER COMPLETING THE CORI UKR PROCEDURE, IT WAS FOUND THAT THE TIP OF THE BONE PIN WAS BROKEN OFF. THE PATIENT WAS NOT HARMED DURING THE PROCEDURE. CORI WAS USED FOR THE ENTIRE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10655708 ↗