TRIGEN 71645050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556215999), received between Sep 3, 2019 and Jan 5, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K111025, K161264, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED APPROXIMATELY THREE MONTHS AGO, THE PATIENT EXPERIENCED A BREAKAGE OF THE INTERTAN 1.5 11.5 MM X 42 CM 130D LT AND THE TRIGEN LOW PROFILE SCREW 5.0 MM X 30 MM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) INTERTAN 1.5 11.5 MM X 42 CM 130D LT, ONE (1) INTERTAN 1.5 11.5 MM X 42 CM 130D LT, ONE (1) INTERTAN SUBTROC LAG 11 X 95 AND ONE (1) TRIGEN LOW PROFILE SCREW 5.0 MM X 30 MM WERE EXPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23956964 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE TRIGEN LOW PROFILE SCREW 5.0MM X 50MM BROKE WHEN IT WAS GOING TO BE SCREW INTO THE SCREWDRIVER DURING HANDLING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118822 ↗
• InjuryApr 6, 2022Break; Break

  IT WAS REPORTED THAT, A TRAUMA SURGERY WAS PERFORMED ON THE (B)(6)2021 TO TREAT A BROKEN FEMUR AND A META-TAN 11.5MM X 44CM RIGHT WAS IMPLANTED. MONTHS LATER, THE BOTTOM SCREWS BROKE, AS WELL AS THE NAIL ITSELF AND THE IMPLANT WAS UNSTABLE WITH A SIGNIFICANT VARUS DEFORMITY OF THE PROXIMAL FEMUR. THE PATIENT UNDERWENT A COMPLEX REVISION SURGERY ON THE(B)(6)2022 TO TREAT THIS ADVERSE EVENT, WHEN THE PATIENT HAD AN ORIF SYSTEM IMPLANTED. THE PATIENT IS RECOVERING.

  Patient problems: Deformity/ Disfigurement; Discomfort; Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain; Unequal Limb Length

  MAUDE report 14022767 ↗
• InjurySep 23, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AFTER A TRIGEN INTERTAN SYSTEM WAS IMPLANTED ON PLAINTIFF LEFT FEMUR ON (B)(6) 2018, THE PLAINTIFF EXPERIENCED INCREASED PAIN ON LEFT KNEE. BY X-RAYS, FAILURE OF THE DISTAL LOCKING SCREWS, DISTAL MIGRATION OF THE TIP OF THE NAIL AND NONUNION OF LEFT SUBTROCHANTERIC FEMUR WERE FOUND. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THESE ADVERSE EVENTS. INTRAOPERATIVELY, IT WAS FOUND THAT THE PROXIMAL ENDS OF 2 DISTAL LOCKING SCREWS WERE BROKEN. THE TRIGEN INTERTAN COMPONENTS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Necrosis; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 12523562 ↗
• InjurySep 3, 2019Break; Break

  IT WAS REPORTED A REVISION SURGERY DUE TO CUT OUT.

  Patient problems: Injury

  MAUDE report 8955496 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, K161264, 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-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