TRIGEN 71642300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010496959), received between May 26, 2017 and Jan 29, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Connection Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K210980, K981529); 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.

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.

• InjuryJan 29, 2018Connection Problem; Connection Problem

  REVISION/EXCHANGE TRIGEN BLUE 6.4MM RECON SCREWS DUE TO BACKING OUT AND PENETRATION ACETABULUM. RIGHT FEMUR.

  Patient problems: No Information

  MAUDE report 7224073 ↗
• InjuryMay 26, 2017Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT POST-OPERATIVE HOSPITAL STAY WAS EXTENDED TO THE PATIENT AND THAT SHE HAD TO REMAIN NON-WEIGHT BEARING FOR 6 WEEKS FOLLOWING TRIGEN TAN NAIL PROCEDURE, SINCE AT SUBSEQUENT XRAY MEETING IT WAS NOTED THAT ONE OF THE 6.4MM SCREWS WAS IN THE FEMORAL HEAD BUT NOT THROUGH THE NAIL.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Therapeutic Response, Decreased

  MAUDE report 6593398 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210980, K981529. 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-0943-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for
• Z-0944-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for