TRIGEN 71118220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010436535), received between Sep 8, 2024 and Feb 14, 2026 — classified as 3 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. 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.

• MalfunctionFeb 14, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY THE END OF ONE (1) 6.00MM FXD ENDCUTTING RMR BROKE OFF WHILE REAMING THE HUMERAL CANAL. BOTH PIECES OF THE BROKEN INSTRUMENT WERE RETRIEVED. THE REAMER AND GUIDE ROD WERE REMOVED AND THE NEXT SIZE REAMER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341300 ↗
• MalfunctionOct 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRIGEN HUMERAL NAIL PROCEDURE, THE DISTAL END OF THE 6.00MM FXD ENDCUTTING RMR HAD BROKEN OFF THE END OF THE REAMER SHAFT AND HAD FALLEN ONTO THE FLOOR AS THE REAMER WAS REMOVED. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO DELAY OR INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441376 ↗
• MalfunctionSep 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A NAIL REAMING PROCEDURE ONE (1) 6.00MM FXD ENDCUTTING RMR BECAME LODGED IN THE PATIENT'S BONE CANAL. DESPITE EFFORTS TO DISLODGE IT, THE SURGEON DECIDED TO PROCEED WITH PLATING AS THE CANAL COULD NOT BE PREPARED FOR THE THINNEST 8/7MM HUMERAL NAIL. WHILE WAITING FOR THE PLATING INSTRUMENTS AND KITS TO ARRIVE, THE SURGEON COMPARED THE 6.00MM FXD ENDCUTTING RMR WITH THE 7.00MM FIXED END-CUTTING REAMER AND OBSERVED THAT THE FORMER APPEARED THICKER. THE SURGEON THEN ATTEMPTED TO USE THE 7.00MM FIXED END-CUTTING REAMER, WHICH PASSED THROUGH THE BONE CANAL WITHOUT DIFFICULTY. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY WITH THE INSERTION OF THE 8/7MM HUMERAL NAIL. UPON RETURN OF THE 6.00MM FXD ENDCUTTING RMR TO THE OSC, THE REAMER TIP WAS MEASURED AND FOUND TO BE 8MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20165937 ↗

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