TRIGEN 71674085Recalls & reported problems
Smith & Nephew, Inc. · SCREW LENGTH SLEEVE · Class 2
All models of TRIGEN (381)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010560827), received between Aug 16, 2021 and May 4, 2022 — classified as 3 malfunctions.
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
- Crack1
- Solder Joint Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2022Solder Joint Fracture; Solder Joint Fracture
IT WAS REPORTED THAT THE SCREW LENGTH SLEEVE IS CRACKED AT THE WELD. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14279642 ↗MalfunctionFeb 7, 2022Break; Break
IT WAS REPORTED THAT A SCREW LENGTH SLEEVE IS BROKEN AT THE WELD. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13470306 ↗MalfunctionAug 16, 2021Crack; Crack
IT WAS REPORTED THAT A RULER HAS BROKEN THREADS, A T-HANDLE HAS BROKEN TABS, A 12.5MM ENTRY REAMER IS DULL AND CHIPPED, A SHORT HEXDRIVER HAS DAMAGED THREADS AND A SCREW LENGTH SLEEVE IS CRACKED AT THE JOINT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12326854 ↗
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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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