TRIGEN 71701016RRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010543134), received between Nov 26, 2018 and Nov 12, 2021 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 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) 2013, IN WHICH A HFN 10MM 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 AFTER TALUS FRACTURE FROM A PREVIOUSLY PERFORMED ARTHRODESIS WITH UNSPECIFIED DEVICES, THE PATIENT EXPERIENCED A POSTOPERATIVE ACUTE RESPIRATORY FAILURE. THE PATIENT WAS TRANSFERRED TO ICU. DESPITE THIS INCIDENT, 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 IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Respiratory Insufficiency

  MAUDE report 12805904 ↗
• 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) 2016, 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 CHARCOT NEUROARTHROPATHY, THE PATIENT EXPERIENCED OSTEOMYELITIS AND ANKLE JOINT NONUNION. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2016 TO EXPLANT THE NAIL ALONG WITH THE SCREWS, BUT IT IS UNKNOWN WHETHER ADDITIONAL DEVICES WERE IMPLANTED IN EXCHANGE. FOLLOWING THE EXPLANTATION OF THE DEVICES, THE PATIENT REQUIRED ON (B)(6) 2017 A BELOW KNEE AMPUTATION, BUT THE INVOLVEMENT OF SMITH AND NEPHEW DEVICES WAS NOT CONFIRMED. 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 12800451 ↗
• 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 10MM X 16XM RIGHT NAIL WAS IMPLANTED WITH TWO SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X1) AND THE DISTAL TRANSVERSE (X1) REGION TO TREAT A POST TRAUMATIC ARTHRITIS, THE PATIENT EXPERIENCED CELLULITIS. THIS ADVERSE EVENT WAS RESOLVED WITH A 10 DAY KEFLEX TREATMENT. A COMPLETE FUSION WAS ACHIEVED AND CONFIRMED BY X-RAY ASSESSMENT THREE 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: Cellulitis

  MAUDE report 12796118 ↗
• InjuryNov 10, 2021Fracture; Fracture

  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 10MM X 16XM RIGHT NAIL WAS IMPLANTED WITH THREE SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X1), DISTAL TRANSVERSE (X1) AND DISTAL POSTEROANTERIOR (X1) REGION TO TREAT A NONUNION OF A PRIOR ANKLE FUSION SURGERY PERFORMED IN AN UNSPECIFIED DATE AND LOCATION, THE PATIENT EXPERIENCED A SUBTALAR NONUNION AND THE FRACTURE OF THE IMPLANTED NAIL. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE EVENT. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED DURING THIS PROCEDURE AND THE IDENTITY OF THE DEVICES IMPLANTED IN EXCHANGE. FURTHERMORE, DURING THIS PROCEDURE A PROXIMAL TIBIAL BONE GRAFT WAS 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: Failure of Implant; Malunion of Bone

  MAUDE report 12790940 ↗
• InjuryNov 10, 2021Fracture; Fracture

  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 10MM X 16CM RIGHT NAIL WAS IMPLANTED ALONG WITH FOUR SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2), DISTAL TRANSVERSE (X1) AND DISTAL POSTEROANTERIOR (X1) REGION TO TREAT A RHEUMATOID ARTHRITIS ON THE ANKLE, SUBTALAR AND TALONAVICULAR JOINTS, THE PATIENT EXPERIENCED AN ANKLE NONUNION WITH A FRACTURED FUSION NAIL IMPLANT THROUGH THE TALAR SCREW HOLE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. THE IS NO CONFIRMATION IN REGARDS OF THE IDENTITY OF THE EXPLANTED DEVICES, AS WELL AS THE DEVICES IMPLANTED IN EXCHANGE. DESPITE THIS INCIDENT, A SUBTALAR FUSION WAS ACHIEVED AND CONFIRMED BY X-RAY ASSESSMENT ON (B)(6) 2019. 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; Malunion of Bone

  MAUDE report 12790056 ↗
• 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) 2017, IN WHICH A HFN 10MM 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 TALUS AVASCULAR NECROSIS, THE PATIENT EXPERIENCED A POSTERIOR WOUND BREAKDOWN AND SOME TIBIAL CORTICAL HYPERTROPHY. THE WOUND BREAKDOWN WAS TREATED WITH ADDITIONAL LOCAL WOUND CARE. FURTHER CT ASSESSMENT PERFORMED ON (B)(6) 2019 DEMONSTRATED A PARTIAL FUSION OF BOTH TREATED HINDFOOT JOINTS. 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: Wound Dehiscence

  MAUDE report 12788161 ↗
• 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) 2014, IN WHICH A HFN 10MM X 16CM RIGHT NAIL WAS IMPLANTED ALONG WITH FOUR SCREWS PLACED ACROSS THE PROXIMAL TIBIAL (X2), DISTAL TRANSVERSE (X1) AND DISTAL POSTEROANTERIOR (X1) REGION TO TREAT A POSTERIOR TIBIAL TENDON DYSFUNCTION AND PES PLANOVALGUS DEFORMITY, THE PATIENT EXPERIENCED PAIN IN THE AREA OF THE POSTEROANTERIOR HEEL SCREW. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2016 TO REMOVE THIS SCREW, ALTHOUGH IT IS UNKNOWN IF AN ADDITIONAL SCREW WAS IMPLANTED IN EXCHANGE. DESPITE THIS INCIDENT, A COMPLETE FUSION IN THE TREATED HINDFOOT JOINTS WAS CONFIRMED BY X-RAY ASSESSMENT 3 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: Implant Pain

  MAUDE report 12787066 ↗
• MalfunctionNov 26, 2018Connection Problem; Device Handling Problem; Connection Problem; Device Handling Problem

  IT WAS REPORTED THAT A MALFUNCTION OCCURRED DURING SURGERY. THE HFN NAIL, OUT OF 5 SCREWS ONLY 3 SCREWS WERE GOING THROUGH THE JIG. REMAINING 2 SCREWS WENT OUT OF THE NAIL WHEN SURGEON TRIED THIS IN CASE. AT THE SAME TIME WHEN SURGEON LOADED THE NAIL ON JIG THE DRILL BIT WENT THROUGH THE HOLES BUT NOT ON TABLE WHEN IT WAS USED WITH PATIENT. THERE WAS A DELAY OF 1 HOUR SINCE THERE WAS NO BACK UP AVAILABLE. SURGEON USED THE TRADITIONAL TECHNIQUE SHE PUT FREE HAND SCREWS WITHOUT JIG. THERE WAS NO AFFECTATION OR INJURY TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101222 ↗

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-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-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-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
• 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