REAL INTELLIGENCE ROB10013SRecalls & reported problems
Smith & Nephew, Inc. · REAL INTELLIGENCE ROBOTIC DRILL · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556780886), received between Sep 28, 2022 and Sep 2, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Nov 13, 2023Open, Classified
Possibility that the user is unable to resolve drill disconnection error messages.
Z-0708-2024 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Connection Problem2
- Detachment of Device or Device Component1
- Difficult to Insert1
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.
MalfunctionSep 2, 2025Difficult to Insert; Connection Problem; Detachment of Device or Device Component; Difficult to Insert; Connection Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI TKA SURGERY, MANY DIFFICULTIES WERE ENCOUNTERED WHILE ATTACHING THE MILLING CUTTER TO ONE (1) REAL INTELLIGENCE ROBOTIC DRILL. THE SYSTEM REPEATEDLY DISPLAYED AN ERROR MESSAGE DURING THE CALIBRATION OF THE CUTTER, DESPITE THE TRACKERS BEING IN PLACE AND THE POINTER BEING IN CONTACT WITH THE CUTTER. HOWEVER, IT WAS MANAGED TO PROCEED WITH THE PROCEDURE, BUT DURING THE CUTTING PHASE THE CUTTER DETACHED FROM THE RI ROBOTIC DRILL. AFTERWARDS, IT WAS UNABLE TO REATTACH IT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP PRODUCT, AND NO DELAY OR INJURIES WERE REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22936170 ↗InjurySep 28, 2022Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING A CORI ASSISTED TKA PROCEDURE, WHEN THE REAL INTELLIGENCE ROBOTIC DRILL WAS CONNECTED TO THE CONSOLE, CONFIRMATION ICON WAS FLICKERING AND THE DRILL COULD NOT BE RECOGNIZED CORRECTLY. THE CUSTOMER RE-CONNECTED THE DRILL BUT THE FAILURE OCCURRED AGAIN. SURGERY WAS RESUMED AFTER A 30-MINUTE DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO NAVIO ASSISTED DUE TO A BACK-UP CORI DRILL WAS NOT AVAILABLE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15500625 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.