TRIGEN 71701020LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010542489), received between Sep 20, 2021 and Jun 14, 2022 — classified as 5 injuries, 1 malfunction.

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

• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TIBIOFIBULAR FRACTURE WITH POSTOPERATIVE BONE DISCONTINUITY AND INTERNAL FIXATION OF PSEUDARTHROSIS, ORTHOPEDIC FUSION AND INTERNAL FIXATION OF BONE GRAFT, HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED SWELLING ON THE LEFT ANKLE WITH OOZING. THIS ADVERSE EVENT WAS ADDRESSED BY DEBRIDEMENT PROCEDURE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bacterial Infection; Swelling/ Edema

  MAUDE report 14690924 ↗
• 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 LEFT HINDFOOT ON (B)(6) 2012, IN WHICH A HFN 10MM X 20CM LEFT NAIL WAS IMPLANTED ALONG WITH THREE SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2) AND DISTAL TRANSVERSE REGION TO TREAT OSTEOMYELITIS ON THE TIBIA, TALUS AND CALCANEUS BONES, THE PATIENT EXPERIENCED SUBTALAR NONUNION AND EQUINUS DEFORMITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 TO TREAT THIS ADVERSE EVENT. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED DURING THIS PROCEDURE, AS WELL AS THE IDENTITY OF THE IMPLANTED DEVICES IN EXCHANGE. 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 12795949 ↗
• 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) 2010, IN WHICH A HFN 10MM X 20XM LEFT NAIL WAS IMPLANTED WITH THREE SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X1), DISTAL TALAR (X1) AND DISTAL TRANSVERSE (X1) REGION TO TREAT A POST-TRAUMATIC ANKLE AND SUBTALAR ARTHRITIS, THE PATIENT REQUIRED AN ADDITIONAL DISTAL TIBIAL OSTEOTOMY TO TREAT A MIDFOOT EQUINUS DEFORMITY ON (B)(6) 2012. DURING THIS PROCEDURE, ALL IMPLANTS WERE REMOVED AS THE PATIENT WAS EXPERIENCING SOME PAIN. THERE IS NO CONFIRMATION ON WHETHER ADDITIONAL DEVICES WERE IMPLANTED IN EXCHANGE. A COMPLETE FUSION WAS ACHIEVED AND CONFIRMED BY X-RAY ASSESSMENT 12 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: Deformity/ Disfigurement; Pain

  MAUDE report 12790897 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 4 YEARS AFTER A PRIMARY TRAUMA SURGERY HAD BEEN PERFORMED ON THE PATIENT'S LEFT HINDFOOT ON (B)(6) 2013, IN WHICH A HFN 10MM X 20CM LEFT NAIL WAS IMPLANTED ALONG WITH THREE SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2) AND DISTAL TRANSVERSE (X1) REGION TO TREAT A POST-TRAUMATIC ANKLE ARTHRITIS, A TIBIAL NONUNION OF A PREVIOUS ATHRODESIS AND VALGUS DEFORMITY, THE PATIENT EXPERIENCED NON UNION OF THE ANKLE AS SEEN ON CT SCAN ON (B)(6) 2017. 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 12790539 ↗
• 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) 2013, IN WHICH A HFN 10MM X 20CM LEFT NAIL WAS IMPLANTED ALONG WITH TWO SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X1) AND DISTAL TRANSVERSE (X1) REGION TO TREAT AN HEMOPHILIAC ARTHRITIS OF THE ANKLE AND SUBTALAR JOINTS, ONE PATIENT EXPERIENCED HEEL PAIN. ALL IMPLANTS WERE REMOVED ON (B)(6) 2014, BUT IT WAS NOT CONFIRMED WHETHER ADDITIONAL PROSTHESIS WERE IMPLANTED IN EXCHANGE. A COMPLETE FUSION IN THE HINDFOOT TREATED JOINTS WAS 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. 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: Implant Pain

  MAUDE report 12790280 ↗
• MalfunctionSep 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED, THAT DURING AN ANKLE ARTHRODESIS SURGERY, A HFN 10MM X 20CM LEFT FAILED TO LOCK IN CORRECTLY. SURGERY WAS COMPLETED, WITH A SIGNIFICANT DELAY, BY USING A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494574 ↗

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-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-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-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-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