REAL INTELLIGENCE ROB10017Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556757369), received between Feb 15, 2024 and Aug 23, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD AND THE REAL INTELLIGENCE ROBOTIC DRILL WERE NOT ABLE TO SEAT IN THE REAL INTELLIGENCE POINT PROBE. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING MANUAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048849 ↗
• MalfunctionJun 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE SETTING UP FOR A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE POINT PROBE FELL TO THE GROUND AND ITS TIP GOT BENT. THE PROCEDURE WAS PERFORMED, AFTER NO DELAY, WITH MANUAL TECHNIQUE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556466 ↗
• MalfunctionMar 23, 2024Failure to Calibrate; Connection Problem; Failure to Calibrate; Connection Problem

  IT WAS REPORTED THAT WHILE SETTING UP FOR A CORI ASSISTED TKA SURGERY, THE SURGICAL TEAM WAS UNABLE TO SUCCESSFULLY CALIBRATE ANY DRILLS WITH THE CORI KNEE TENSIONER CARTRIDGE PLUGGED IN. 3 DRILLS WERE TRIED ON, CONSISTENTLY GOT ERRORS WHILE CALIBRATING THEM AND AT ONE POINT THE SCREEN STARTED TO TURN A RAINBOW COLOR AND WOULD BLACK OUT AND NOT COME BACK ON. AT THIS POINT THEY HAD TRIED 3 DRILLS, NEW FLAT MARKERS, NEW LONG ATTACHMENTS AND NOTHING WAS WORKING. THE PROCEDURE WAS PERFORMED USING MANUAL TECHNIQUE BUT IT IS UNKNOWN IF THERE WAS ANY DELAY. FURTHERMORE, THE 3 DRILLS WERE TESTED, WITHOUT THE TENSIONER, AND THEY ALL CALIBRATED PERFECTLY. LATER ON, THE TENSIONER WAS PLUGGED BACK IN AND TRIED TO CALIBRATE THE DRILLS (THE TENSIONER CALIBRATED FINE) BUT THEN GOT THE RAINBOW SCREEN AGAIN AND WAS UNABLE TO CALIBRATE THE DRILLS. FINALLY, THEY TRIED A DIFFERENT USB PORT, WHICH RESULTED IN SUCCESSFUL CALIBRATION, THEN THEY WENT BACK TO THE FIRST PORT AND SUCCESSFULLY CALIBRATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965621 ↗
• MalfunctionFeb 28, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING CORI ASSISTED UKR SURGERY, THE POINTER TIP OF THE REAL INTELLIGENCE POINT PROBE SEEMS TO BE BENT ON THE BALL POINT TIP. THE POINTER TIP PASSES CALIBRATION SET UP STAGE WITH NO ISSUES BUT WHEN MORPHING THE FEMUR IT IS COMPLETELY OFF THE PARK WITH SETTING UP THE 3D MESH MORPH. IT SEEMS TO BE BENT ON THE BALL POINT TIP. SURGERY, WAS RESUMED AFTER A SIGNIFICANT DELAY WITH A S+N BACK-UP DEVICE. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798650 ↗
• MalfunctionFeb 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING CORI ASSISTED UKR SURGERY, THE TIP OF THE REAL INTELLIGENCE POINT PROBE WAS BENT WHEN TRYING TO LOCATE THE POSTERIOR TIBIAL POINT IN THE TIGHT UNI KNEE SITUATION. THIS POINTER PASSED HAND PIECE CALIBRATION BUT WHEN MORPHING THE TIBIAL BONE IT DISTORTS THE 3 D MESH THAT IS MAPPED AND IT IS COMPLETELY OFF THE MARKS. SURGERY WAS RESUMED AFTER A SIGNIFICANT DELAY WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711151 ↗