REAL INTELLIGENCE ROB10021Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556757406), received between Dec 10, 2021 and Mar 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING PIN PLACEMENT IN A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE DRILL GUIDE WAS USED AND THE PINS BIND UP AND GOT STUCK. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694360 ↗
• MalfunctionDec 10, 2021Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE PINS GOT STUCK IN THE REAL INTELLIGENCE DRILL GUIDE. THEY USED A MALLET TO HELP MAKE THE REAL INTELLIGENCE DRILL GUIDE UNSTUCK. IT MIGHT BE BENT. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975709 ↗