TRIGEN 71653236Recalls & reported problems
Smith & Nephew, Inc. · TRIGEN META RETROGRADE FEMORAL NAIL 11.5MM X 36CM · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010548436), received between Sep 30, 2022 and Sep 30, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
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.
MalfunctionSep 30, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, A META RETRO FEM NAIL 11.5 X 36 WAS CROSS THREADING. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15514773 ↗
Other NAIL, FIXATION, BONE devices
- NA 03.043.024Synthes GmbH · NAIL, FIXATION, BONE234 reports
- NA 03.010.440Synthes GmbH · NAIL, FIXATION, BONE70 reports
- TRIGEN 71676627Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall2 reports
- TRIGEN 71676628Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall0 reports
- NA 03.043.018Synthes GmbH · NAIL, FIXATION, BONE33 reports
- TRIGEN 71675383Smith & Nephew, Inc. · NAIL, FIXATION, BONE29 reports
- NA 03.010.441Synthes GmbH · NAIL, FIXATION, BONE27 reports
- NA 03.010.435Synthes GmbH · NAIL, FIXATION, BONE24 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.