TRIGEN 71676627Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556131633), received between Apr 11, 2022 and May 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (K040212, K210980); 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.

Recalls naming this device

1. Apr 22, 2022Open, Classified

   Right nails were anodized, marked, and labelled as left nails and vice versa

   Z-1133-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, AN INTERTAN 1.5 13X42 130D LT WAS OPENED, AND IT APPEARED NORMAL. WHEN ATTACHED TO THE TARGETER, IT WOULD ONLY ATTACH IN THE ¿REVERSE¿ AS A RIGHT NAIL WOULD. FURTHER, INSPECTION SHOWED A LIME GREEN NAIL, CLEARLY MARKED LEFT THAT APPEARS TO ACTUALLY BE A RIGHT NAIL INCORRECTLY COLORED AND LABELED. REPLACEMENT/ALTERNATE HAD TO BE RETRIEVED. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14355662 ↗
• InjuryApr 11, 2022Activation, Positioning or Separation Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY IN WHICH THE PATIENT NEEDED A LEFT NAIL, AN INTERTAN 1.5 13X42 130D LEFT NAIL WAS SELECTED AND IMPLANTED, BUT IT DID NOT FIT CORRECTLY. THE NAIL PENETRATED THROUGH THE ANTERIOR CORTEX SO IT WAS EXPLANTED. UPON INSPECTION, IT WAS NOTICED THAT THE NAIL CONFIGURATION WAS RIGHT, BUT IT HAD BEEN COLOURED, MARKED AND BOXED AS LEFT. THE PROCEDURE WAS COMPLETED, AFTER 30 MIN, BY USING AN INTERTAN 1.5 13X44 130D LEFT NAIL.

  Patient problems: Perforation

  MAUDE report 14079904 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-0772-2021 · Nov 2, 2020 · Terminated
  Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long
• Z-0097-2018 · Oct 24, 2017 · Open, Classified
  smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
• Z-2258-2014 · Jul 2, 2014 · Terminated
  TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71
• Z-1636-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204,
• Z-1637-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree