TRIGEN 71655136Recalls & reported problems
Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 10MM X 36CM · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010585585), received between May 10, 2017 and Dec 5, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (3 reports).
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
- Fracture3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant2
- Injury2
- Pain2
- Bone Fracture(s)1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT INDICATED THAT ON (B)(6) 2023 THE META-NAIL TIBIAL 10MM X 36CM THAT WAS IMPLANTED BROKE IN HALF CASING PAIN AND ANGULATION OF THE SITE. THE SURGEON WHO IMPLANTED THE DEVICE DRILLED HOLES IN IT TO SECURE IT WITH MORE HARDWARE, BUT IT STILL BROKE. ON (B)(6) 2023 A REVISION SURGERY WAS PERFORMED IN ORDER TO REPLACE THE BROKEN NAIL. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.
Patient problems: Bone Fracture(s); Failure of Implant; Pain
MAUDE report 18267466 ↗InjuryJun 5, 2019Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A SUSPECTED INFECTION.
Patient problems: Injury
MAUDE report 8670177 ↗InjuryJun 5, 2019Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO NON UNION OF FRACTURE.
Patient problems: Injury
MAUDE report 8670176 ↗InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A NAIL WAS EXPLANTED. IMPLANTATION WAS DONE SEVERAL YEARS AGO WITH NO ISSUES. THE PATIENT WAS IN A CAR ACCIDENT RECENTLY AND DEVELOPED PAIN AROUND THE NAIL. SURGEON WOULD LIKE THE NAIL EXAMINED TO SEE IF IT SUSTAINED ANY DAMAGE FROM THE ACCIDENT WHICH LEAD TO THE PATIENT'S PAIN.
Patient problems: Failure of Implant; Pain
MAUDE report 6556425 ↗
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.