TRIGEN 71674092Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010560834), received between Aug 11, 2021 and Apr 18, 2023 — classified as 5 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K123598); 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.

• MalfunctionApr 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE BEGINNING OF A TRAUMA SURGERY, THE ENTRY PORTAL HANDLE DEVICE WAS IMPACTED AND THE IMPACTION AND MANIPULATION HANDLE FRACTURED, SLOWING DOWN THE PROCEDURE, THE BROKEN PIECE WAS REMOVED AND REPLACED BY THE 3.2MM THREADED PIN. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765418 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT THE ENTRY PORTAL IS BROKEN AT SHAFT AND HEAD CONNECTION. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583497 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE TUBE A TRIGEN ENTRY PORTAL HANDLE BECAME LODGED IN HANDLE COUPLING AND BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF SURGERY WAS DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791771 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT A ENTRY PORTAL HANDLE IS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656954 ↗
• MalfunctionAug 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, A GRIPPER AND A ENTRY PORTAL HANDLE BROKE. NO FURTHER DETAILS AVAILABLE AT THIS TIME. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307393 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116