TRIGEN 71645060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556216194), received between Jun 18, 2021 and Oct 1, 2024 — classified as 3 injuries.

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

5 other recalls cover devices cleared under the same FDA submission (K111025, K161264, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Fracture; Fracture

  IT WAS REPORTED, AFTER AN INTRAMEDULARY NAIL REVISION PERFORMED ON (B)(6) 2020 DUE TO THE BACKING OUT OF THE TRIGEN LOW PROFILE SCREW 5.0MM X 55MM AND THE BREAKAGE OF THE TRIGEN LOW PROFILE SCREW 5.0MM X 67.5MM. LATER, THE PATIENT REQUIRED AN ADDITIONAL REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE DISTAL INTERLOCKING SCREWS DUE TO THE BREAKAGE OF THE TRIGEN LOW PROFILE SCREW 5.0MM X 60MM. A NEW SMITH & NEPHEW 57.5MM AND 67.5 MM INTERLOCKING SCREWS WERE IMPLANTED IN EXCHANGE.

  Patient problems: Failure of Implant

  MAUDE report 20347929 ↗
• InjuryAug 24, 2024Fracture; Fracture

  IT WAS REPORTED, AFTER AN INTRAMEDULLARY NAIL REVISION PERFORMED ON (B)(6) 2020 DUE TO DISTAL SCREW BREAKAGE AND DISTAL SCREW BACKING OUT, THE PATIENT REQUIRED AN ADDITIONAL REVISION SURGERY ON(B)(6) 2020 TO REPLACE THE DISTAL INTERLOCKING SCREWS DUE TO THE BREAKAGE OF THE TRIGEN LOW PROFILE SCREW 5.0MM X 60MM. A NEW 57.5 MM AND 67.5 MM INTERLOCKING SCREWS WERE IMPLANTED IN EXCHANGE. NO FURTHER INFORMATION ON THE PATIENT'S OUTCOME IS KNOWN.

  Patient problems: Cancer; Failure of Implant; Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture

  MAUDE report 20058785 ↗
• InjuryJun 18, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, A 5.0 X 60 TRIGEN LP SCREW BROKE INSIDE THE PATIENT, WHICH RESULTED IN PAIN. IN ORDER TO RESOLVE THIS PROBLEM, THE BROKEN SCREW AND THE REST OF THE HARDWARE WERE TAKEN OUT AND REPLACED ON (B)(6) 2021; HOWEVER, PART OF THE BROKEN SCREW WAS LEFT INSIDE BY SURGEON'S CHOICE. PATIENT IS FINE NOW.

  Patient problems: Pain

  MAUDE report 12022896 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, K161264, 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