REAL INTELLIGENCE ROB10022Recalls & reported problems
Smith & Nephew, Inc. · REAL INTELLIGENCE CHECKPOINT TOOL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556757413), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).
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
- Difficult or Delayed Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2022Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE SURGEON SUCCESSFULLY PUT ONE CHECKPOINT PIN INTO THE FEMUR USING THE REAL INTELLIGENCE CHECKPOINT TOOL. THE SURGEON THEN TRIED TO MOVE ON TO PUT IN THE SECOND CHECKPOINT PIN, HOWEVER THE CHECKPOINT PIN WOULD NOT RELEASE FROM THE TOOL AFTER BEING MALLETED INTO THE TIBIA. THE SURGEON WAS ABLE TO DISCONNECT THE CHECKPOINT PIN FROM THE TOOL USING BRUTE FORCE, HOWEVER IT PULLED THE CHECKPOINT PIN OUT OF THE BONE WHEN DOING SO. IT WAS TRIED AGAIN WITH A DIFFERENT CHECKPOINT PIN WITH NO CHANGE. THE PROCEDURE WAS COMPLETED, WITHOUT SIGNIFICANT DELAYS, BY INSERTING THE SECOND CHECKPOINT PIN IN A NEW SPOT, WITH A KOCHER INSTEAD OF THE CHECKPOINT TOOL. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13537174 ↗
Other Orthopedic stereotaxic instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
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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