TRIGEN 71701020RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010542496), received between Nov 13, 2018 and Dec 13, 2024 — classified as 4 injuries.

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

11 other recalls cover devices cleared under the same FDA submission (K043052, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A RIGHT ANKLE ARTHRODESIS PERFORMED ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM 22 THROUGH (B)(6) 2020 FOR OSTEOMYELITIS OF THE RIGHT LOWER EXTREMITY WITH PSEUDOMONAS INFECTION. THIS ADVERSE EVENT WAS TREATED WITH ANTIBIOTICS. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Medical device site infection

  MAUDE report 20925123 ↗
• InjurySep 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, FOLLOWING A RIGHT HINDFOOT ARTHRODESIS PROCEDURE PERFORMED ON (B)(6) 2023, THE NAIL BROKE AT THE DISTAL LOCKING END. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2023 AT THE SCHULTHESSKLINIK ZÜRICH. THE CURRENT PATIENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17789973 ↗
• InjuryJun 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A AFTER A HINDFOOT ARTHRODESIS PERFORMED ON AN UNKNOWN DATE, EVEN THOUGH THE SURGICAL FUSION SITE AT TIBIAL TALUS JUNCTION HAD HEALED WELL, THE PATIENT REPORTED PAIN IN THE NAIL AND APPEARS FRACTURED AT NON FUSED JOINT. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT, AND DURING SURGERY IT WAS CONFIRMED THAT THE HFN 10MMX20CM RIGHT BROKE IN SITU THROUGH CALCANEUS/ TALUS SCREW HOLE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 14789123 ↗
• InjuryNov 13, 2018Break; Break

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO ANKLE PAIN. TRIGEN NAIL IMPLANTED WAS FOUND BROKEN. NO DELAY OR BACK UP REPORTED.

  Patient problems: Injury

  MAUDE report 8066568 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043052, 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-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-2087-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulat
• Z-2085-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulation
• Z-2082-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulation
• Z-2088-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulat
• Z-2086-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulation
• Z-2084-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulati
• Z-2083-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulati