Trigen E0015116-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556665749), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THE DEEP-FLUTED 13.0MM END CUTTING REAMER BROKE INSIDE PATIENT. A LITTLE PIECE OF THE BROKEN DEVICE WAS LEFT INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15122203 ↗