TRIGEN 71118234Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010409423), received between Jun 24, 2020 and Feb 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Fracture; Material Deformation; Premature Separation; Fracture; Material Deformation; Premature Separation

  IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS PROCEDURE, ONE (1) 10.0MM PILOT NOSE IRH WAS DAMAGED BY BECOMING UNCOUPLED FROM THE REAMER AND GETTING STUCK IN THE OLIVE GUIDE FALLING INTO THE PATIENT'S BONE, BUT IT WAS REMOVED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374602 ↗
• MalfunctionApr 11, 2021Flaked; Flaked

  IT WAS REPORTED THAT, THERE IS METAL COMING OFF THE SIDES OF ALL 9.0MM ENDCUTTING IRH REAMER HEADS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646937 ↗
• MalfunctionSep 10, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THERE ARE NO NUMERICAL MARKINGS VISIBLE ON THE FLEX REAMER ENDS AND NURSING OFTEN MIX UP THE REAMER ENDS WHEN THEY ARE BEING ASKED FOR BY THE SURGEON. EVENT OCCURRED DURING SURGERY, WITH INSTRUMENTS OUTSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. A SURGICAL DELAY OF 30 MIN OR LESS WAS REPORTED. NO HARM TO PATIENT WAS REPORTED DUE TO THIS FAILURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10517940 ↗
• MalfunctionJun 24, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE REAMER WAS FOUND CHIPPED AND NEEDED TO BE REPLACED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10188439 ↗

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