TRIGEN 71631117Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010437792), received between May 23, 2022 and Aug 24, 2023 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K093047); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A MET-NAIL RETROGRADE FEMUR CASE, ONE (1) 4.0MM SHORT DRILL BROKE, IT SNAPPED MID-SHAFT. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17617656 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, A 4.0MM SHORT DRILL FAILED AT THE MOMENT OF USE, EVIDENCING THE RUPTURE OF THE INSTRUMENT. SURGERY WAS COMPLETED WITH THE SAME DEVICES. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14479588 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434