TRIGEN 71631192Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010419743), received between Jun 16, 2020 and Oct 22, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• InjuryOct 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, AFTER REAMING WITH THE DEVICE, IT WAS OBSERVED THAT THE SHAFT PART OF A TRIGEN FLEXIBLE REAMER SHAFT WITH CIRCULAR CONNECTOR BROKE OFF, INSTRUMENT GOES INSIDE THE PATIENT. NOTHING FELL INTO THE WOUND. 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 12682461 ↗
• MalfunctionDec 22, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE FLEXIBLE REAMER SHAFT 50CM FAILED. THE TIP OF THE DEVICE IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM HAPPENED INSIDE THE PATIENT OR NOT. NO DELAY OR BACK UP HAVE BEEN CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056141 ↗
• MalfunctionDec 1, 2020Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION FLEXIBLE REAMER SHAFT 50 CM WAS FOUND TO BE BROKE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10927254 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT, DURING ROUTINE INSPECTION, PART OF THE FLEXIBLE REAMER SHAFT WAS FOUND TO BE BROKEN. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10907769 ↗
• InjuryJun 16, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE FLEXIBLE REAMER SHAFT 50CM BROKE AT MODIFIED HUDSON JUNCTION WHILE USING INTERNAL TO THE PATIENT. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10158027 ↗

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