REAL INTELLIGENCE ROB10031Recalls & reported problems
Smith & Nephew, Inc. · REAL INTELLIGENCE TUBING SET · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556757468), received between May 11, 2021 and May 12, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Inability to Irrigate” (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
Device problems
- Inability to Irrigate2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2021Inability to Irrigate; Inability to Irrigate
IT WAS REPORTED THAT DURING A TKA SURGERY THE IRRIGATION DIDN¿T WORK DURING MILLING. THE IRRIGATION TUBING WAS ABLE TO PRIME OUTSIDE OF THE PUMP DURING MILLING, BUT ONCE IT WAS PLACED THE TUBING BACK WITHIN THE PUMP THERE WAS NO IRRIGATION. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A BULB IRRIGATION. IT IS UNKNOWN IF THIS WAS A TUBING OR A CONSOLE ISSUE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11813031 ↗InjuryMay 11, 2021Inability to Irrigate; Inability to Irrigate
IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE IRRIGATION DIDN'T WORK DURING FEMORAL MILLING. THE PUMP WAS PUMPING AND THE IRRIGATION TUBING WAS ABLE TO PRIME OUTSIDE OF THE PUMP, BUT ONCE IT WAS PLACED THE TUBING BACK WITHIN THE PUMP NO WATER CAME OUT. NO ONE WAS STANDING ON THE TUBING, NO DEFECTS PRESENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A BULB IRRIGATION. IT IS UNKNOWN IF IT WAS A TUBING (B)(4) OR A CONSOLE (B)(4) ISSUE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11805809 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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