TRIGEN 71701116LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010543165), received between Apr 15, 2019 and Nov 11, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A PRIMARY TRAUMA SURGERY HAD BEEN PERFORMED ON THE PATIENT'S LEFT HINDFOOT ON (B)(6) 2014, IN WHICH A HFN 11.5MM X 16CM LEFT NAIL WAS IMPLANTED ALONG WITH FOUR SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2), DISTAL TRANSVERSE (X1) AND DISTAL POSTEROANTERIOR (X1) REGION TO TREAT A POST-TRAUMATIC ANKLE & SUBTALAR ARTHRITIS. THE PATIENT EXPERIENCED THE FRACTURE OF THE NAIL THROUGH THE TALAR SCREW HOLE. DESPITE THIS INCIDENT, A COMPLETE FUSION IN THE TREATED HINDFOOT JOINTS WAS CONFIRMED BY X-RAY ASSESSMENT 3 MONTHS POSTOPERATIVELY. THE REPORTED INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IN REGARDS OF HOW WAS THIS INCIDENT TREATED AND/OR RESOLVED IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Failure of Implant

  MAUDE report 12801319 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY TRAUMA SURGERY HAD BEEN PERFORMED ON THE PATIENT'S LEFT HINDFOOT ON (B)(6) 2012, IN WHICH A HFN 11.5MM X 16CM LEFT NAIL WAS IMPLANTED ALONG WITH FOUR SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2), DISTAL TRANSVERSE (X1) AND DISTAL POSTEROANTERIOR (X1) REGION TO TREAT AVASCULAR NECROSIS OF THE TALUS, THE PATIENT EXPERIENCED NONUNION OF ANKLE AND SUBTALAR JOINTS, CORTICAL HYPERTROPHY AND A LOOSENING OF THE POSTEROANTERIOR DISTAL SCREW. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 TO TREAT THIS ADVERSE EVENT. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED DURING THIS PROCEDURE, AND AN UNSPECIFIED FUSION PLATE WAS IMPLANTED INSTEAD. THE TRANSVERSE SCREW WAS PREVIOUSLY REMOVED ON A PROCEDURE PERFORMED ON (B)(6) 2014. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Failure of Implant; Malunion of Bone

  MAUDE report 12788017 ↗
• InjuryApr 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTED HFN. IMPLANT WAS REPLACED WITH AN ANTIBIOTIC-CEMENTED HFN AS A TEMPORAL FIX THAT WILL BE REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 8512783 ↗

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-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-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-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-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-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
• 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-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-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