TRIGEN 71640740Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556341445), received between May 4, 2022 and Dec 17, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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.

• MalfunctionDec 17, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE META-TAN LAG/COMP KIT 75/70 MISSED THE META-TAN 11.5MM X 40CM RIGHT BY APPROXIMATELY 90 DEGREES. NAIL WAS REMOVED AND ATTACHED TO JIG AND "ALTHOUGH SOME MOVEMENT, NOWHERE NEAR ENOUGH TO MISS THE NAIL WITH THE SCREWS". ADDITIONAL HOLES HAD TO BE MADE, CONFIRMED JIG GAVE THE CORRECT TRAJECTORY. THERE WAS A DELAY GREATER THAN 30 MINUTES AND THE PROCEDURE WAS FINISHED USING AN INTERTAN NAIL INSTEAD. PATIENT WAS NOT HARMED.

  Patient problems: Perforation

  MAUDE report 20952336 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT DURING A RIGHT FEMUR REMOVAL OF HARDWARE, REVISION OF NONUNION AND IM NAILING WITH ORIF ON (B)(6) 2021, THE PATIENT SUFFERED FROM ACUTE BLOOD LOSS ANEMIA AND HYPOKALEMIA. THE PATIENT RECEIVED A BLOOD TRANSFUSION TO MAINTAIN HGB LEVELS STABLE. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Anemia; Bruise/Contusion; Hemolytic Anemia

  MAUDE report 14283536 ↗

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