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TRIGEN 71642260Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN INTERNAL HEX CAPTURED SCREW 5.0MM X 60MM · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010465047), received between Aug 25, 2017 and Aug 25, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1
  • Insufficient Device Problem Information1

Patient problems

  • Bone Fracture(s)1
  • Injury1
  • Pain1

Recent adverse event reports

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

  • InjuryAug 25, 2017Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFOMED DUE TO PROXIMAL SCREW BREAKING AFTER THREE MONTHS OF ORIGINAL IMPLANT.

    Patient problems: Bone Fracture(s); Injury; Pain

    MAUDE report 6819964 ↗

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-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-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

Other NAIL, FIXATION, BONE devices

All NAIL, FIXATION, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.