TRIGEN 71655130Recalls & reported problems
Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 10MM X 30CM · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010585547), received between Sep 29, 2024 and Dec 10, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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 Problem1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHEN PLACING THE META-NAIL TIBIAL 10MM X 30CM, THE OLIVE-SHAPED GUIDE DID NOT COME OUT, REQUIRING THE NAIL TO BE REMOVED AND RE-INSERTED, WHICH DID NOT REDUCE THE NAIL AND NECESSITATING ITS COMPLETE REMOVAL. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A COMPETITOR'S DEVICE. PATIENT WAS ANESTHETIZED DURING THE DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23773957 ↗InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, FOLLOWING AN LEFT-TIBIAL INTRAMEDULLARY NAILING PROCEDURE WITH EXTENSIVE DEBRIDEMENT PERFORMED ON (B)(6) 2018 DUE TO INFECTED HARDWARE AND FRACTURE NONUNION, THE PATIENT SUSTAINED A LEFT HIP SEPTIC ARTHRITIS AND FEMUR OSTEOMYELITIS WHICH REQUIRED AN ADDITIONAL PROCEDURE ON (B)(6) 2020 TO REMOVE A PRIOR DYNAMIC COMPRESSION SCREW (UNKNOWN MANUFACTURER) WITH EXTENSIVE DEBRIDEMENT OF NECROTIC TISSUE AND INFECTED BONE, PULSE IRRIGATION AND VANCOMYCIN POWDER PLACEMENT. 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 20329546 ↗
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.