TRIGEN 71640742Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556341490), received between Sep 22, 2021 and Dec 9, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, FOLLOWING A RIGHT IMN FIXATION PROCEDURE PERFORMED ON (B)(6) 2021 TO REDUCE A PERTROCHANTERIC FEMORAL FRACTURE, THE PATIENT REQUIRED A REVISION SURGERY WITH NAIL EXCHANGE & GRAFT PLACEMENT ON (B)(6) 2022 DUE TO PARTIAL UNION OF THE FRACTURE LINE. AS PER THE X-RAYS INTERPRETED BY THE HEALTHCARE PROFRESSIONAL, THE NAIL WAS BENT AORUND THE PROXIMAL SCREWS. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20883927 ↗
• InjuryJul 19, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, ONE (1) META-TAN 11.5MM X 42CM RIGHT WAS INSERTED IN THE USUAL MATTER, HOWEVER AFTER REMOVING THE JIG, IT WAS DISCOVERED THAT THE INTEGRATED SCREW HAD MISSED, ANTERIOR TO THE NAIL. IT WAS ADVISED THAT IT WAS A COMPLICATED CASE. NOTE THAT THE JIG WAS ALIGNED PRIOR TO AND ONCE AGAIN AFTER THE CASE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR PRODUCT. NO FURTHER INFORMATION AVAILABLE AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785046 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 7 MONTHS AFTER A PROCEDURE HAD BEEN PERFORMED WITH TRIGEN TRAPTAN 11.5MM X 42CM RIGHT TO TREAT A SIMPLE LONG BONE FRACTURE IN THE MIDSHAFT REGION OF THE FEMUR, THE PATIENT REPORTED SOME LIMITED PAIN AND THE GENERAL OUTCOME WAS NOT SUCCESSFUL, AS THE FRACTURE WAS NOT COMPLETELY REDUCED. A REVISION SURGERY WAS PERFORMED TO TREAT THIS ADVERSE EVENT. THE TRIGEN TRAPTAN 11.5MM X 42CM RIGHT WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED NAIL, WITH THE SUBSEQUENT UNION OF THE FRACTURE. IT IS UNKNOWN HOW MUCH TIME TOOK TO ACHIEVE THE REPORTED FINAL OUTCOME. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 12512602 ↗

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