TRIGEN 71701116RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010543172), received between Nov 10, 2020 and Oct 2, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY WAS PERFORMED ON SOME DAY OF (B)(6), THE NAIL HFN 11.5MMX16CM RIGHT IMPLANTED IN THE PATIENT BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, 8 MONTHS AFTER THE PRIMARY PROCEDURE, TO ADDRESS THIS COMPLICATION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17851600 ↗
• 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 RIGHT HINDFOOT ON (B)(6) 2015, IN WHICH A HFN 11.5MM X 16CM RIGHT NAIL WAS IMPLANTED ALONG WITH FOUR SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2), DISTAL TRANSVERSE (X1) AND DISTAL TALAR (X1) REGION TO TREAT A POST-TRAUMATIC ANKLE & SUBTALAR ARTHRITIS AND VALGUS DEFORMITY, THE PATIENT EXPERIENCED AN ANKLE NONUNION AND PAIN IN THE PLANTAR REGION. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2017 TO TREAT THIS ADVERSE EVENT. THE NAIL WAS REMOVED ALONG WITH THE FOUR SCREWS, BUT IT WAS NOT CONFIRMED IF AN ADDITIONAL CONSTRUCT WAS IMPLANTED IN EXCHANGE. 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 IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Malunion of Bone

  MAUDE report 12790703 ↗
• 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 RIGHT HINDFOOT ON (B)(6) 2012, IN WHICH A HFN 11.5 MM X 16 CM RIGHT NAIL WAS IMPLANTED ALONG WITH TWO SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X1) AND DISTAL TRANSVERSE (X1) REGION TO TREAT A TIBIAL PILON FRACTURE-DISLOCATION, THE PATIENT EXPERIENCED A LATERAL ANKLE ABSCESS WHICH WAS TREATED WITH A ICD. ALL HARDWARE WAS REMOVED ON (B)(6) 2012, BUT THERE IS NO CONFIRMATION ON WHETHER ADDITIONAL DEVICES WERE IMPLANTED IN EXCHANGE. A COMPLETE FUSION WAS CONFIRMED BY X-RAY ASSESSMENT 15 MONTHS 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: Abscess

  MAUDE report 12786625 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE LOCKING SCREW WAS NOT INSERTED THROUGH THE NAIL THAT GOES FROM THE CALCANEUS TO THE CUBOID. IT WAS VERIFIED THAT THE SYSTEM WAS CORRECTLY MOUNTED AND NO FAILURE WAS FOUND. IT IS PRESUMED THAT THE FAILURE OCCURRED IN THE INSERTED NAIL BUT WAS NOT CONFIRMED. PROCEDURE WAS CONCLUDED WITH A DELAY OF LESS THAN 30 MINUTES WITH THE SAME NAIL. NO OTHER SCREW WAS PLACED SO A VOID WAS LEFT IN THE BONE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10814877 ↗

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-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-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-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
• 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-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