TRIGEN 71637234Recalls & reported problems
Smith & Nephew, Inc. · TROCHANTERIC ANTEGRADE NAIL LIME 10MM X 34CM LEFT · Class 2 · Implant
Data updated Oct 13, 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 03596010458070), received between Aug 18, 2022 and Aug 18, 2022 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K981529); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AS PART OF A CLINICAL STUDY TITLED "ARE TAN NAILS SAFE AND EFFECTIVE FOR FEMUR FRACTURES IN ADOLESCENTS?", NINETY FIVE (95) PATIENTS UNDERWENT PRIMARY IMPLANTATION OF EITHER A TRIGEN ADOLESCENT TAN OR A TRIGEN TAN INTRAMEDULLARY NAIL TO TREAT TRAUMA FRACTURES ON THE FEMUR. FROM THIS COHORT, ONE (1) PATIENT IN THE TRIGEN TAN GROUP REQUIRED A REVISION SURGERY DUE TO HARDWARE FAILURE. ADDITIONAL DETAILS REGARDING THE FAILURE MODE EXPERIENCED ARE YET TO BE CONFIRMED. THE PATIENT'S OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Failure of Implant
MAUDE report 15249998 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K981529. One submission often covers many models, so check the product and lot details in each record.
- Z-0944-2013 · Feb 7, 2013 · TerminatedINTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for
- Z-0943-2013 · Feb 7, 2013 · TerminatedINTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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