TRIGEN 71675523Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556344842), received between Aug 10, 2017 and Jun 10, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K040212, K241804); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, DURING AN IM NAIL PROCEDURE, THE INTERTAN 10S 10MM X 26CM 125D RIGHT WAS IMPLANTED IN THE LEFT FOOT BY MISTAKE. THIS WAS NOTICED WHEN THE DISTAL SCREW WAS BEING FASTENED. SALES REP SUGGESTED REPLACING THE DEVICE, HOWEVER, SURGEON WAS CONCERNED ABOUT THE FIXATION FORCE MIGHT BE REDUCED. SURGERY WAS RESUMED, WITH A 40 MINUTES DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659468 ↗
• InjuryJun 9, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT, DURING SURGERY, CALIBRATION OF THE DEVICE WAS PERFORMED OUTSIDE THE PATIENT TO CONFIRM THE ALIGNMENT OF A DRILL AND DISTAL SCREW HOLES ON THE NAIL; HOWEVER, IT WAS FOUND THAT THE TIP OF THE DRILL INTERFERED WITH THE NAIL. THE PROCEDURE WAS COMPLETED ALMOST FREE HAND (THE DEVICE WAS USED, HOWEVER WITHOUT RELYING ON THE DEVICE). SURGERY WAS DELAYED FOR 15 MINUTES. THE PATIENT WAS NOT HARMED. AFTER THE SURGERY, THE SALES REP CONFIRMED THAT THE DEVICE WORKED CORRECTLY WITH OTHER NAIL, SO THE COMPLAINED DEVICE IS THE NAIL THAT REMAINS IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10135527 ↗
• InjuryNov 5, 2019Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE SURGEON FOUND A SHADOW IN A X-RAY IMAGE. AFTER RECONFIRMING THE IMAGE, HE FOUND SOMETHING REMAINED. THEN THE SAME SURGERY WAS PERFORMED AGAIN USING OTHER IMPLANTS/DEVICES. AFTER PULLING OUT THE NAIL PREVIOUSLY IMPLANTED, A METALLIC PIECE WAS REMOVED FROM THE MEDULLARY SPACE. THEN REMOVING THE METAL MATERIALS AS MUCH AS POSSIBLE, THE SURGERY WAS COMPLETED BY IMPLANTING OTHER NAIL. BACK-UPS AVAILABLE. DELAY GREATER THAN 30 MIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9281435 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PROCEDURE, THE NAIL FOR RIGHT LEG WAS INSERTED IN THE LEFT LEG OF THE PATIENT. NOTICED WHEN DISTAL SCREW COULD NOT BE IMPLANTED CORRECTLY. INTERVENTION PERFORMED IS UNSPECIFIED. A DELAY OF 30 MINUTES WAS REPORTED. INJURIES ARE UNSPECIFIED.

  Patient problems: Injury

  MAUDE report 8378687 ↗
• InjuryAug 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO NAIL BREAKAGE. THERE WAS BAD REDUCTION POSITION IN THE BONE. THE SYNOSTOSIS WAS NOT COMPLETED UNTIL HALF YEAR.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6784931 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212, K241804. One submission often covers many models, so check the product and lot details in each record.

• Z-1133-2022 · Apr 22, 2022 · Open, Classified
  INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
• Z-0772-2021 · Nov 2, 2020 · Terminated
  Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long
• Z-0097-2018 · Oct 24, 2017 · Open, Classified
  smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
• Z-2258-2014 · Jul 2, 2014 · Terminated
  TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71
• Z-1636-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204,
• Z-1637-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree