TRIGEN 71645075Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556216491), received between Aug 16, 2023 and Dec 3, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER FEMORAL NAILING FOLLOWING A HIGH ENERGY INJURY ON (B)(6) 2023, THE PATIENT HAD A BONE DEFECT. THEN, ON (B)(6) 2024 TWO DISTAL SCREWS WERE REMOVED TO ALLOW DYNAMIZATION. THE PATIENT RECENTLY EXPERIENCE PAIN AND AN X-RAY SHOWED A BROKEN DISTAL SCREW. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE NAIL HAS BEEN REPLACE AND BONE GRAFT HAS BEEN PLACED TO ADDRESS THE BONE DEFECT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 23704741 ↗
• InjuryAug 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT FEMORAL INTRAMEDULLARY FRACTURE FIXATION ON (B)(6) 2021 AS A RESULT OF A BICYCLE ACCIDENT, THE PATIENT EXPERIENCED MIDDLE DISTAL INTERLOCKING SCREW BREAKAGE AND PROXIMAL DISTAL INTERLOCKING SCREW LOOSENING THAT CAUSED A 2 MM SHORTENING OF DISTAL SEGMENT, IN CONJUNCTION WITH RIGHT HYPERTROPHIC FEMORAL SHAFT NONUNION FRACTURE. THE PATIENT EXPERIENCED PAIN AND AMBULATION DIFFICULTIES THAT REQUIRED THE USE OF A WALKER. THESE COMPLICATIONS WERE TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE INTERNAL FIXATION HARDWARE WAS REMOVED AND REPLACED WITH A COMPETITOR¿S INTRAMEDULLARY NAIL-SCREW SYSTEM (DEPUY SYNTHES). PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17557390 ↗

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