TRIGEN 71642235Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010464996), received between Jun 5, 2020 and May 13, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K210980, K981529); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO A FALL ON (B)(6) 2020, A PATIENT EXPERIENCED A RIGHT TIBIAL FRACTURE WHICH REQUIRED A TEMPORARY TREATMENT WITH AN EXTERNAL FIXATOR ON (B)(6) 2020. THIS EXTERNAL FIXATOR WAS REMOVED ON (B)(6) 2020 AND AFTER A RIGHT TIBIAL INTERNAL INFIXATION SURGERY WITH TRIGEN LOW PROFILE SCREW 5.0MM X 35MM PERFORMED THE SAME DAY, THE PATIENT EXPERIENCED SECRETION AND WOUND HEALING PROBLEMS WITH THE PRESENCE OF STAPHYLOCOCCUS AUREUS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE TRIGEN LOW PROFILE SCREW 5.0MM X 35MM (X2), INT HEX CAP SCR 5.0MM X 35MM, TRIGEN LOW PROFILE SCREW 5.0MM X 40MM AND TRIGEN LOW PROFILE SCREW 5.0MM X 55MM WERE EXPLANTED DURING THIS REVISION SURGERY. IT IS UNKNOWN IF THE EXPLANTED DEVICE WAS SUBSTITUTED WITH A SMITH AND NEPHEW IMPLANT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Abrasion; Bacterial Infection

  MAUDE report 11817086 ↗
• InjuryJun 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REVISION SURGERY TO REMOVE TRIGEN RETROGRADE FEMORAL NAIL (INITIAL INSERTION DATE (B)(6) 2019, REVISION SURGERY DATE (B)(6) 2020) THE THREADS OF THE 2 PROXIMAL INTERNAL HEX CAPTURE SCREWS DISASSEMBLED DURING REMOVAL AND FURTHERMORE FELL INTO THE MEDULLARY CANAL. THE SURGEON HAD A HARD TIME TO REMOVE THEM AND THE SURGERY WAS DELAYED BY MORE THAN 30 MINS. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: Injury

  MAUDE report 10122876 ↗
• InjuryJun 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REVISION SURGERY TO REMOVE TRIGEN RETROGRADE FEMORAL NAIL (INITIAL INSERTION DATE (B)(6) 2019, REVISION SURGERY DATE (B)(6) 2020) THE THREADS OF THE 2 PROXIMAL INTERNAL HEX CAPTURE SCREWS DISASSEMBLED DURING REMOVAL AND FURTHERMORE FELL INTO THE MEDULLARY CANAL. THE SURGEON HAD A HARD TIME TO REMOVE THEM AND THE SURGERY WAS DELAYED BY MORE THAN 30 MINS. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: Injury

  MAUDE report 10122833 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210980, K981529. 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-0943-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for
• Z-0944-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for