TRIGEN 71701120RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010543196), received between Apr 3, 2019 and Nov 11, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 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 RIGHT HINDFOOT ON (B)(6) 2011, IN WHICH A HFN 11.5MM X 20CM RIGHT NAIL WAS IMPLANTED ALONG WITH THREE SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2) AND DISTAL TRANSVERSE (X1) REGION TO TREAT A COMMINUTED TIBIAL PILON AND TALUS FRACTURE, THE PATIENT EXPERIENCED A POSTOPERATIVE HEMATOMA WHICH REQUIRED AN ADDITIONAL SURGERY ON (B)(6) 2011 TO PERFORM A DRAINAGE. A COMPLETE FUSION WAS ACHIEVED AND CONFIRMED BY X-RAY ASSESSMENT 6 WEEKS POSTOPERATIVELY, ALTHOUGH IT IS UNKNOWN IF THE REPORTED TIME FRAME IS RELATED TO THE PRIMARY SURGERY OR TO THE ADDITIONAL INTERVENTION PERFORMED. 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: Hematoma

  MAUDE report 12800308 ↗
• InjuryApr 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, PATIENT HAD AN IATROGENIC FRACTURE IN THE LATERAL TIBIAL SHAFT DUE TO CHANGE IN THE SURGICAL TECHNIQUE DELAY FROM (0-30) MINUTES REPORTED.

  Patient problems: Injury

  MAUDE report 8480904 ↗

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-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-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-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-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