TRIGEN 71655036Recalls & reported problems
Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 8.5MM X 36CM · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010585509), received between Oct 24, 2019 and Nov 19, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
Patient problems
- Injury1
- Nonunion/Delayed-union Bone Fracture1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PERFORMED ON (B)(6) 2025, AT THE 3 MONTH POST OP APPOINTMENT IT WAS FOUND THAT THE FRACTURE HADN'T HEALED AND THERE WAS ROTATION OF THE FOOT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXCHANGE THE META-NAIL TIBIAL 8.5MM X 36CM AND SCREWS. ACCORDING TO THE SURGEON, THERE WAS NO ISSUE WITH THE NAIL ITSELF. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 23594238 ↗InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, FOLLOWING AN INTRAMEDULLARY NAIL FIXATION OF A PILON FRACTURE OF THE RIGHT TIBIA PERFORMED ON (B)(6) 2018 DUE TO PRIOR HARDWARE BREAKAGE (UNKNOWN PLATE AND SCREWS), THE PATIENT SUSTAINED A SURGICAL SITE INFECTION ON (B)(6) 2019 THAT REQUIRED THE REMOVAL OF DEEP ORTHOPEDIC HARDWARE WITH IRRIGATION & DEBRIDEMENT AND PLACEMENT OF ANTIBIOTIC IMPREGNATED RESORBABLE BEADS. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 20329559 ↗InjuryOct 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT HAD A TIBIAL NAIL INSERTED APPROX 5 MONTHS AGO. DUE TO DELAYED UNION DR. DECIDED TO EXCHANGE THE NAIL FOR ONE WITH A LARGER DIAMETER.
Patient problems: Injury
MAUDE report 9234033 ↗
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.