TRIGEN 71634020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010495730), received between Nov 20, 2019 and Nov 25, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

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.

• MalfunctionNov 25, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE FINAL PHASE OF THE PROCEDURE, THE PROXIMAL CAP DID NOT JOIN TO NAIL. THE INDICATED PROCEDURE WAS DONE, BUT THESE DID NOT ADAPT PROPERLY TO THE NAIL, THEREFORE, ANOTHER CAP WAS OPENED BUT THIS ALSO FAILED, THE PATIENT WAS LEFT WITHOUT A CAP. IT IS UNKNOWN IF THE PROBLEM IS ASSOCIATED WITH THE PLUGS OR THE NAIL. THE PATIENT'S HEALTH CONDITION IS STABLE. DELAY 30 MINUTES -1 HOUR REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9373542 ↗
• MalfunctionNov 20, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE FINAL PHASE OF THE PROCEDURE, THE PROXIMAL CAP DID NOT JOIN TO NAIL. THE INDICATED PROCEDURE WAS DONE, BUT THESE DID NOT ADAPT PROPERLY TO THE NAIL, THEREFORE, ANOTHER CAP WAS OPENED BUT THIS ALSO FAILED, THE PATIENT WAS LEFT WITHOUT A CAP. IT IS UNKNOWN IF THE PROBLEM IS ASSOCIATED WITH THE PLUGS OR THE NAIL. THE PATIENT'S HEALTH CONDITION IS STABLE. DELAY 30 MINUTES -1 HOUR REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9350107 ↗

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-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
• 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