TRIGEN 71645025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556215494), received between Oct 16, 2020 and Jun 22, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K111025, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; 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 LOOSENING OF DISTAL SCREWS, SECRETION AND WOUND HEALING PROBLEMS WITH THE PRESENCE OF STAPHYLOCOCCUS AUREUS IN THE AREA OF DISTAL LOCKING. THERE WAS ALSO AN ADJACENT EXTENSIVE FLUID DEPOSIT IN THE SUBCUTANEOUS ADIPOSE TISSUE. X-RAY SCANS SHOWED THAT THERE WAS A PROXIMAL LOCKING SCREW PERFORATED WHICH LATER ON DURING REVISION SURGERY WAS NOTICED BROKEN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE TRIGEN LOW PROFILE SCREW 5.0MM X 25MM WAS EXPLANTED DURING THIS REVISION SURGERY. DESPITE OF THE TIBIAL FRACTURE BEING DIAGNOSED AS "SOMEWHAT SUBMERGED AND SHORTENED", THE SURGEON ADVISED THAT THE HEALING PROCESS OF THE INCOMPLETELY CONSOLIDATED FRACTURE CAN BE AWAITED, BUT THERE IS A RISK OF PSEUDOARTHROSIS FORMATION. FOR THIS, AN ADDITIONAL SURGERY WILL BE DISCUSSED AND EVALUATED WITH THE P

  Patient problems: Bacterial Infection; Impaired Healing

  MAUDE report 12046396 ↗
• MalfunctionApr 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING INTERTAN TRAUMA SURGERY, IT WAS FOUND THAT THE TRIGEN LOW PROFILE SCREW 5.0MM X 25MM (CASE: (B)(4)) AND THE LONG HEXDRIVER (CASE: (B)(4)) MATED INCORRECTLY. THE SURGERY WAS COMPLETED WITH A LESS THAN 30 MINS DELAY USING OTHER SMITH AND NEPHEW BACK-UP SCREW. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683496 ↗
• InjuryOct 16, 2020Defective Device; Defective Device

  WHILE ATTENDING A SHORT INTERTAN NAIL FOR A NECK OF FEMUR (NOF) ON A YOUNG FEMALE WITH STRESS FRACTURE TO INFERIOR NECK, IT WAS FOUND THICKENED CORTICES FROM LONG HISTORY OF STEROID USE FOR IMMUNE DISORDER. A CANAL REAMING WAS PLANNED TO ACCOMMODATE 10MM 20CM NAIL. DURING THE PROCEDURE, A SHORT INTERTAN NAIL WAS CHOSEN, IT WAS ATTACHED TO DRILL GUIDE (DRILL GUIDE HANDLE) AND DROP (125 RAD DRILL GDE DROP) , THE NAIL WAS INTRODUCED OVER BALL TIP GUIDE WIRE. PROXIMAL ICS SCREW GUIDE PIN ADVANCED USING ACCORDING DROP, IT WAS DIFFICULT TO ADVANCE GUIDE PIN TO 25MM TIP APEX (MARKED RESISTANCE). LAG DRILL (INTERTAN LAG SCREW DRILL) ADVANCED OVER GUIDE WIRE WITH MUCH DIFFICULTY TO THE REQUIRED DEPTH (LAG SCREW WAS TAPPED TO GET TO THE REQUIRED DEPTH). BLACK SUBSTANCE NOTED IN FLUTES OF DRILL. THEN THE COMPRESSION DRILL (7.0MM COMPRESSION SCREW DRILL) MET SIMILAR RESISTANCE BUT COULD GET THE REQUIRED DEPTH. A DISTAL LOCKING WAS ATTEMPTED THROUGH THE INTERTAN DROP, IT MARKED RESISTANCE USING THE DRILL. A LATERAL X-RAY CONFIRMED SCREW WAS NOT IN THE NAIL BUT POSTERIOR TO IT, SCREW REMOVED AND NO FURTHER ATTEMPT TO DISTAL LOCK WAS UNDERTAKEN. A DELAY OF LESS THAN 30 MIN WAS REPORTED. PROCEDURE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10689799 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, 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-1132-2013 · Mar 6, 2013 · Terminated
  TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery