TRIGEN 71640640Recalls & reported problems
Smith & Nephew, Inc. · META-TAN NAIL 10MM X 40CM RIGHT · Class 2 · Implant
All models of TRIGEN (381)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00885556340349), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
1 other recall cover devices cleared under the same FDA submission (K092748, K243364); they may or may not involve this specific model.
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
- Fracture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Fracture
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION HAD BEEN PERFORMED ON (B)(6) 2025, PATIENT EXPERIENCED FRACTURE OF THE PROXIMAL LOCKING SCREW OF THE NAIL DURING WEIGHT-BEARING PROGRESSION (APPROXIMATELY 50 KG PARTIAL WEIGHT-BEARING). THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2026, DURING WHICH, THE META-TAN 10MM X 40CM RIGHT WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24722827 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092748, K243364. One submission often covers many models, so check the product and lot details in each record.
- Z-1806-2025 · Mar 18, 2025 · Open, ClassifiedMETA-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
- NA 03.033.001Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES265 reports
- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 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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