TRIGEN 71649838Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556341940), received between Nov 20, 2023 and Nov 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING INTERNAL FIXATION SURGERY ON (B)(6) 2021 IN WHICH A META-TAN NAIL WAS PLACED, THE OUTCOME WAS DEEMED UNSUCCESSFUL: THE FRACTURE DID NOT HEAL TOGETHER AS EXPECTED. THIS ADVERSE EVENT WAS TREATED BY SCHEDULING A REVISION SURGERY ON (B)(6) 2023.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18172435 ↗
• InjuryNov 20, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A META-TAN NAIL REVISION CONDUCTED ON (B)(6) 2023, IT WAS NOT POSSIBLE TO REMOVE THE META-TAN 13MM X 38CM LEFT AND THE META-TAN LAG/COMP KIT 90/85 IMPLANTS DUE TO HARDWARE LODGE IN CANNULATION. AFTER A SURGICAL DELAY OF MORE THAN 60 MIN, IT WAS DECIDED TO LEAVE THE IMPLANTS IN SITU. AN ADDITIONAL SURGERY WAS REQUIRED ON (B)(6) 2023, IN WHICH IMPLANTS WERE SUCCESSFULLY REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18172422 ↗

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