TRIGEN 71631039Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010605542), received between Apr 26, 2021 and Jan 30, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A FEMUR OSTEOSYNTHESIS PROCEDURE WHEN THE CUTTING WAS BEING CARRIED OUT IN THE PROXIMAL SEGMENT OF THE FEMUR ONE (1) ONE-PIECE 14MM CHANNEL REAMER FRACTURE, BUT WITH A FORCEPS IT WAS POSSIBLE TO REMOVE THE FRAGMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607750 ↗
• MalfunctionMar 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE ONE-PIECE 14MM CHANNEL REAMER DEVICE BROKE. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 16616862 ↗
• MalfunctionJan 4, 2022Flaked; Material Twisted/Bent; Naturally Worn; Flaked; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT A ONE-PIECE 14MM CHANNEL REAMER IS WORN, FADED, CHIPPED AND BENT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154575 ↗
• MalfunctionSep 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE PIN OF A ONE-PIECE 14MM CHANNEL REAMER FELL OUT OF THE TOP. THIS HAPPENED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12472101 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING A NAIL SURGERY, THE ONE-PIECE 14MM CHANNEL REAMER IS BROKEN. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729672 ↗

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