TRIGEN 71701016LRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010543127), received between Jun 17, 2019 and Nov 11, 2021 — classified as 12 injuries.

The most frequently reported specific device problem is “Fracture” (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 12 most recent of 12 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 LEFT HINDFOOT ON (B)(6) 2014, IN WHICH A HFN 10MM X 16CM LEFT NAIL WAS IMPLANTED ALONG WITH TWO SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X1) AND THE DISTAL TRANSVERSE (X1) REGION TO TREAT A BIMALLEOLAR FRACTURE-DISLOCATION, THE PATIENT EXPERIENCED AN ANKLE NONUNION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO TREAT THIS ADVERSE EVENT. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED DURING THIS PROCEDURE, AS WELL AS THE IDENTITY OF THE PROSTHESIS IMPLANTED IN EXCHANGE. DESPITE THIS INCIDENT, A COMPLETE FUSION IN THE TREATED SUBTALAR REGION WAS CONFIRMED BY X-RAY ASSESSMENT 6.75 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 IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Malunion of Bone

  MAUDE report 12801323 ↗
• 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 16CM LEFT NAIL WAS IMPLANTED ALONG WITH THREE SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2) AND DISTAL TRANSVERSE (X1) REGION TO TREAT AN ANKLE CHARCOT NEUROARTHROPATHY, THE PATIENT EXPERIENCED A DEEP ABSCESS. AN ADDITIONAL SURGERY WAS PERFORMED ON 15(B)(6) 2013 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, AN INCISION AND DEBRIDEMENT WAS PERFORMED, AND THE IMPLANTS WERE REMOVED. IT IS UNKNOWN WHETHER ADDITIONAL PROSTHESIS WERE IMPLANTED IN EXCHANGE. A COMPLETE FUSION WAS CONFIRMED BY X-RAY ASSESSMENT 6.5 MONTHS 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: Abscess

  MAUDE report 12796181 ↗
• 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) 2016, IN WHICH A HFN 10MM X 16CM RIGHT NAIL WAS IMPLANTED ALONG WITH FOUR SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2), DISTAL TALAR (X1) AND DISTAL POSTEROANTERIOR (X1) REGION TO TREAT A TIBIAL PILON FRACTURE WITH VALGUS DEFORMITY, THE PATIENT EXPERIENCED A TIBIAL CORTICAL HYPERTRHOPHY. 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 RELATED TO THE PATIENT'S FINAL OUTCOME IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Extraskeletal ossification

  MAUDE report 12790576 ↗
• 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) 2014, IN WHICH A HFN 10MM 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 PES CAVOVARUS DEFORMITY WITH ANKLE & SUBTALAR ARTHRITIS, THE PATIENT EXPERIENCED A FRACTURE OF THE NAIL THROUGH THE TALAR SCREW HOLE AND A FRACTURE OF THE POSTEROANTERIOR DISTAL SCREW. DESPITE THIS COMPLICATION, A COMPLETE FUSION IN THE TREATED HINDFOOT JOINTS WAS CONFIRMED BY X-RAY ASSESSMENT 4 YEARS 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 ADVERSE TREATED IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Failure of Implant

  MAUDE report 12787980 ↗
• 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) 2014, IN WHICH A HFN 10MM 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 PRIMARY OSTEOARTHRITIS OF THE ANKLE AND SUBTALAR JOINTS, THE PATIENT EXPERIENCED DVT WHILE BEING TREATED WITH LOVENOX. 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: Thrombosis/Thrombus

  MAUDE report 12787496 ↗
• 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 16CM LEFT NAIL WAS IMPLANTED ALONG WITH THREE SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X1), DISTAL TIBIAL (X1) AND DISTAL TALAR (X1) REGION TO TREAT A POST-TRAUMATIC ANKLE & SUBTALAR ARTHRITIS, THE PATIENT EXPERIENCED PAIN ASSOCIATED TO THE IMPLANTED DEVICES. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2015 TO REMOVE THE NAIL. THERE IS NO CONFIRMATION ON WHETHER THIS IMPLANT WAS REPLACED WITH SMITH AND NEPHEW BACK UP DEVICE. 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 12787456 ↗
• 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) 2014, IN WHICH A HFN 10MM 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 PRIMARY OSTEOARTHRITIS OF THE ANKLE AND SUBTALAR JOINTS, THE PATIENT EXPERIENCED AN ANKLE JOINT NONUNION, A FRACTURE OF THE NAIL THROUGH THE TALAR SCREW HOLE AND PAIN IN THE TRANSVERSE HEEL DISTAL SCREW. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2015 TO REMOVE THE TRANSVERSE HEEL SCREW, BUT THERE IS NO CONFIRMATION WHETHER THE NAIL AND/OR SOME OR ALL OF THE REST OF THE SCREWS WERE EXPLANTED. THERE IS ALSO NO CONFIRMATION ON WHETHER AN ADDITIONAL SCREW AND/OR NAIL BEEN IMPLANTED IN EXCHANGE OF THE EXPLANTED SCREW. 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; Implant Pain; Malunion of Bone

  MAUDE report 12787035 ↗
• 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) 2017, IN WHICH A HFN 10MM X 16CM 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 EQUINUS CONTRACTURE, THE PATIENT EXPERIENCED A LATERAL WOUND BREAKDOWN. AN ADDITIONAL WOUND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2017 TO TREAT THIS ADVERSE EVENT. 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: Impaired Healing; Tissue Breakdown; Wound Dehiscence

  MAUDE report 12786989 ↗
• 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) 2014, IN WHICH A HFN 10MM X 16CM 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 TALUS AVASCULAR NECROSIS, THE PATIENT EXPERIENCED TIBIAL OSTEOMYELITIS AND AN ANKLE NONUNION. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6)2015 TO TREAT THIS ADVERSE EVENT. IT IS UNKNOWN WHICH DEVICES WHERE EXPLANTED DURING THIS PROCEDURE, AS WELL AS IF THERE WERE ADDITIONAL PROSTHESIS IMPLANTED IN EXCHANGE. DURING THIS PROCEDURE, A TIBIAL CRATERIZATION WAS ALSO 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: Malunion of Bone; Osteomyelitis

  MAUDE report 12786944 ↗
• 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) 2017, IN WHICH A HFN 10MM X 16CM 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 PRIMARY OSTEOARTHRITIS LOCATED IN AN UNSPECIFIED JOINT AND A POSTERIOR TIBIAL TENDON DYSFUNCTION, THE PATIENT EXPERIENCED AN ANKLE NONUNION OF THE JOINT. AN REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS OUTCOME. DURING THIS PROCEDURE, ALL IMPLANTS WERE REMOVED AND A PROXIMAL TIBIAL BONE GRAFT WAS PERFORMED. THE IDENTITY OF THE DEVICES IMPLANTED IN EXCHANGE IS UNKNOWN AT THIS TIME. UNLIKE THE OUTCOME OF THE ANKLE JOINT, A SUBTALAR FUSION WAS ACHIEVED AND CONFIRMED BY X-RAY ASSESSMENT 3 MONTHS POSTOPERATIVELY, ALTHOUGH IT IS UNKNOWN IF THIS TIME FRAME IS RELATED TO THE PRIMARY SURGERY OR TO THE REVISION SURGERY 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: Malunion of Bone

  MAUDE report 12786808 ↗
• InjuryJun 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 2ND REVISION OF THE HFN TO REMOVE THE 10MMX16CM LEFT CEMENTED VERSION SIZED WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 8725377 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IS NOW THE 3RD REVISION OF THE HFN TO REMOVE THE ABOVE CEMENTED VERSION SIZED. PATIENT WAS STILL INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 8704289 ↗

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-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-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-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-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-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