TRIGEN 71701120LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010543189), received between Aug 5, 2020 and Jun 27, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, A PATIENT UNDERWENT A HINDFOOT ARTHRODESIS PROCEDURE THAT WAS PERFORMED IN THE LEFT FOOT ON (B)(6) 2019. A CLINIC NOTE DATED (B)(6) 2023 INDICATED THAT X-RAYS WERE TAKEN AND APPEARED TO REVEAL A NAIL FRACTURE BELOW THE PROXIMAL OBLIQUE SCREW. A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023 DUE TO BREAKAGE OF THE NAIL. THE PATIENT IS UNDER NORMAL POSTOPERATIVE COURSE WITH A NORMAL WOUND HEALING PROCESS. NO FURTHER COMPLICATION HAVE BEEN REPORTED AFTER THIS PROCEDURE.

  Patient problems: Failure of Implant; Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17210987 ↗
• InjuryAug 22, 2022Migration; Migration

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A HEX CAPTURED SCREW OF 5.0MM COMING OUT OF THE DISTAL HOLE IN THE HINDFOOT NAIL. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 15267199 ↗
• 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) 2011, IN WHICH A HFN 10MM X 16XM RIGHT NAIL WAS IMPLANTED ALONG WITH ONE SCREW (COMPETITORS) PLACED ACROSS THE TIBIAL REGION AND ONE SCREW (COMPETITORS) PLACED ACROSS THE DISTAL TRANSVERSE REGION TO TREAT A CHARCOT LEFT ANGLE AND A SEVERE VALGUS DEFORMITY, THE PATIENT EXPERIENCED A NONUNION OF THE ANKLE JOINT. A COMPLETE FUSION OF THE SUBTALAR AND TALONAVICULAR JOINT WAS ACHIEVED AND CONFIRMED BY X-RAY ASSESSMENT 6 MONTHS POSTOPERATIVELY. 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: Malunion of Bone

  MAUDE report 12789937 ↗
• InjuryNov 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A PRIMARY TRAUMA SURGERY HAD BEEN PERFORMED ON THE PATIENT'S LEFT HINDFOOT ON (B)(6) 2017, IN WHICH A HFN 11.5MM X 20CM LEFT 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 AN ANKLE EQUINUS CONTRACTURE, THE PATIENT EXPERIENCED OSTEOMYELITIS AND A FRACTURE ON THE NAIL IMPLANT THROUGH THE TALAR SCREW HOLE. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2018 TO REMOVE ALL HARDWARE. DURING THIS PROCEDURE, A CRATERIZATION OF THE TIBIA, TALUS AND CALCANEUS WAS ALSO PERFORMED, ALONG WITH AN INSERTION OF ANTIBIOTIC CEMENT ROD. THERE IS NO CONFIRMATION ON WHETHER ADDITIONAL DEVICES WERE IMPLANTED AFTER THIS PROCEDURE. 22 MONTHS AFTER THIS PROCEDURE, A COMPLETE FUSION OF THE TREATED HINDFOOT JOINTS WAS NOTED AS CONFIRMED BY X-RAY ASSESSMENT. 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: Failure of Implant; Osteomyelitis

  MAUDE report 12787123 ↗
• InjuryJun 2, 2021Break; Break

  IT WAS REPORTED THAT AFTER AN INTERNAL FIXATION SURGERY, THE HFN 11.5MMX20CM LEFT BROKE ABOVE THE MOST SUPERIOR DISTAL SCREW (THE CLAC TO TALUS SCREW) AFTER IT WAS IMPLANTED ON (B)(6) 2020. REVISION SURGERY HAS BEEN SCHEDULE AND RESCHEDULED TO REMOVE. THE PROCEDURE TO REMOVE HAS NOT HAPPENED YET. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922033 ↗
• InjuryAug 5, 2020Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY OF A TRIGEN HINDFOOT NAIL LEFT WAS PERFORMED SINCE THE NAIL BROKE AT THE MOST SUPERIOR DISTAL SCREW CLUSTER DUE TO SUBTALAR NON-UNION. THE NAIL WAS IMPLANTED IN THE PATIENT FOR OVER A YEAR.

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

  MAUDE report 10368906 ↗

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-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-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-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-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-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-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