ECTRA 4116Recalls & reported problems
Smith & Nephew, Inc. · ECTRA II PROCEDURE KIT, SINGLE-USE, DISPOSABLE. CONTENTS PROBE KNIFE, RETROGRADE KNIFE, TRIANGLE KNIFE, HAND PAD, SWABS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010122148), received between May 19, 2021 and Sep 20, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
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.
InjurySep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE COTTON OF THE ECTRA II PROCEDURE KIT ON THE COTTON SWAB CAME OFF THE STICK EASY. THE COTTON THAT HAD FALLEN INTO THE BODY WAS REMOVED FROM THE BODY IN AN OPEN SURGERY. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20272974 ↗MalfunctionMay 19, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE, OUTSIDE THE PATIENT, IT WAS FOUND A BLACK FOREIGN MATERIAL INTO THE ECTRA PROCEDURE KIT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. 10 MINUTES OF SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11850156 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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