ECTRA 4144SRecalls & reported problems
Smith & Nephew, Inc. · ECTRA II CARPAL LIGAMENT SYSTEM, DIRECT-VIEW, 4.0 MM, 30 DEGREE, 100 DEGREE WORKING LENGTH, SAME SIDE CANNULA CONNECTION SERVICE REPLACEMENT · 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 03596010122629), received between May 6, 2019 and Feb 11, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2021Break; Break
IT WAS REPORTED THAT DURING A KNEE SCOPE THE SCOPE BROKE INSIDE THE PATIENT, ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR FURTHER COMPLICATIONS REPORTED. PATIENT CURRENT STATUS IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11313353 ↗MalfunctionMay 6, 2019Scratched Material
IT WAS REPORTED THAT DURING A WRIST SCOPE, THE DEVICE WAS SCRATCHED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE WITH NO DELAY AND NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8582803 ↗
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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 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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