TRIGEN 71674062Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010560575), received between Apr 28, 2021 and May 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 16MM CHANNEL REAMER CAME APART. IT IS UNKNOWN IF BROKEN PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES HAVE BEEN REPORTED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367609 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TRIGEN INTERTAN NAIL PROCEDURE, THE HOLDING PIN OF ONE (1) 16MM CHANNEL REAMER BECAME LOOSE AND FELL OUT, THEREFORE, THE REAMER CAME APART. ALL PARTS WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883116 ↗
• MalfunctionApr 28, 2021Loose or Intermittent Connection; Incomplete or Inadequate Connection; Loose or Intermittent Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SET UP/INSPECTION FOR IM NAIL SURGERY THE 16MM CHANNEL REAMER WAS LOOSE AND DID NOT ATTACH TO THE 12.5 REAMER. THE SURGERY CONTINUED WITHOUT ANY SIGNIFICANT DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742458 ↗

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