TRIGEN 71645460Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556217740), received between May 23, 2023 and May 23, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K111025, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, AFTER THE META-NAIL TIBIAL 8.5MM X 32CM WAS INSERTED AND THE DISTAL LOCKING WAS DONE, THE SURGEON PLACED THE TRIGEN LOW PROFILE SCREW 4.5MM X 60MM AND X-RAYED. THE X-RAY SHOWED THAT THE SCREW HAD COME OUT THE PROXIMAL LATERAL TIBIAL PLATEAU. THE SURGEON THINKS THIS IS A DESIGN FAULT OF THE NAIL, AS THE TIBIA HAD A POSTERIOR SLOPE, BUT WITH THE HERZOG BEND OF THE NAIL, THE SCREWS HAVE AN ANTERIOR SLOPE. HE BELIEVES THE SCREWS SHOULD BE SLOPED POSTERIOR ALSO. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY REMOVING THE SCREW AND PLACING IT IN A LOWER HOLE. A VOID WAS LEFT IN BONE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 16988957 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, 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-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• 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-1132-2013 · Mar 6, 2013 · Terminated
  TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery