TRIGEN 71118238Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010409461), received between Jun 24, 2020 and May 25, 2022 — classified as 1 injury, 4 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.

• MalfunctionMay 25, 2022Break; Break

  IT WAS REPORTED THAT A 12.0MM PILOT NOSE INTERCHANGE REAMER HEAD WAS FOUND DULL/CHIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501377 ↗
• MalfunctionApr 27, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE 12.0MM PILOT NOSE INTERCHANGE REAMER HEAD IS DULL AND CHIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14227037 ↗
• InjuryOct 22, 2020Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT THE EDGE OF THE BLADES BROKE AFTER THE REAMER HIT THE K-WIRE. THE SURGEON USED A 2.4 MM K-WIRE TO BLOCK DURING REAMING. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10722583 ↗
• MalfunctionSep 15, 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. THE FAILURE IN THE REAMERS WAS NOT RELATED TO A SURGERY. NO HARM TO ANY 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 10538864 ↗
• 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 10188550 ↗

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