TRIGEN 71640840Recalls & reported problems
Smith & Nephew, Inc. · META-TAN NAIL 13MM 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556342541), received between Jan 8, 2025 and Jan 15, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2025Fracture; Fracture
IT WAS REPORTED THAT AFTER INTERNAL FIXATION, THE PATIENT EXPERIENCED A META-TAN 13MM X 40CM RIGHT FRACTURE. THIS ADVERSE EVENT WAS RESOLVED/TREATED BY REVISION SURGERY ON (B)(6) 2024 TO REMOVE IT FROM PATIENT. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 21161314 ↗InjuryJan 8, 2025Fracture; Fracture
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PERFORMED ON (B)(6) 2024, A (1) META-TAN 10MM X 40CM RIGHT BROKE INSIDE THE PATIENT ON (B)(6) 2024. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024 IN WHICH THE META-TAN 10MM X 40CM RIGHT WAS EXPLANTED AND THE PATIENT WENT THROUGH A COMPETITOR TOTAL HIP REPLACEMENT. PATIENT'S STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21102515 ↗
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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