TRIGEN 71640538Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556339190), received between Apr 16, 2020 and May 7, 2024 — classified as 2 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K092748, K243364); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED ON AN UNKNOWN DATE, A TRIGEN META-TAN NAIL PRESENTED AN UNSPECIFIED FAILURE THAT RESULTED IN A FEMUR FRACTURE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 19264971 ↗
• InjuryApr 16, 2020Break; Break

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE AT (B)(6) MEDICAL CENTER, THE META-TAN NAIL WAS FOUND BROKEN INSIDE THE PATIENT. THE NAIL WAS SUPPOSED TO BE EXPLANTED AND REPLACED WITH A COMPETITOR PRODUCT. THE ITEM BROKE AT THE DISTAL END AT THE POINT OF ONE OF THE SCREW HOLES. ALL PIECES WERE RECOVERED.

  Patient problems: Injury

  MAUDE report 9968593 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092748, K243364. One submission often covers many models, so check the product and lot details in each record.

• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690