TRIGEN 71655034Recalls & reported problems
Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 8.5MM X 34CM · Class 2 · Implant
- 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 03596010585479), received between Feb 24, 2025 and Feb 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2025Fracture; Fracture
IT WAS REPORTED THAT AFTER UNDERGOING AN INTERNAL FIXATION ON AN UNKNOWN DATE, PATIENT EXPERIENCED NAIL BREAKAGE AROUND DISTAL LOCKING SCREWS. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE META-NAIL TIBIAL 8.5MM X 34CM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 21446118 ↗
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.