TRIGEN 71653240Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010548450), received between Aug 19, 2022 and Dec 6, 2024 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT FEMUR ORIF PERFORMED ON (B)(6) 2016 DUE TO AN OPEN FEMORAL FRACTURE. HER RECOVERY COURSE WAS COMPLICATED BY INFECTION IN THE MEDIAL TIGH WOUND WHERE THE ORIF OCCURRED AND UNDERWENT TWO I&DS ON 27 AND (B)(6) 2016. 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: Unspecified Infection

  MAUDE report 20867528 ↗
• InjuryAug 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM INFLAMMATORY REACTION AROUND THE IMPLANTS SECTION AFTER HAVING A FRACTURE FIXATION SURGERY OF THE LEFT TIBIA USING THE TRIGEN TIBIAL META-NAIL SYSTEM, AND A LEFT FEMUR FIXATION USING THE TRIGEN FEMORAL META-NAIL SYSTEM. THE PATIENT UNDERWENT AN UNPLANNED HARDWARE REMOVAL ON (B)(6) 2023. THE PATIENT ACHIEVED UNION AT 35 WEEKS AFTER THE PRIMARY SURGERY. PRIMARY FIXATION SURGERY WAS PERFORMED ON (B)(6) 2016 AFTER A SERIOUS MOTOR VEHICLE ACCIDENT.

  Patient problems: Bacterial Infection; Fluid Discharge; Impaired Healing; Inflammation; Osteomyelitis; Pain

  MAUDE report 20058822 ↗
• InjuryDec 20, 2022Fracture; Off-Label Use; Fracture; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM THE BREAKAGE OF THE DISTAL MOST INTERLOCKING SCREWS IN THE NAIL AFTER HAVING A FRACTURE FIXATION SURGERY OF THE RIGHT FEMUR USING THE TRIGEN RETROGRADE FEMORAL NAIL SYSTEM. IT IS UNKNOWN IF THE PATIENT ACHIEVED UNION AFTER THE PRIMARY SURGERY. NO HARDWARE REVISION SURGERY WAS SCHEDULED, AND THE PATIENT WAS LOST TO FOLLOW UP. ROBUST CALLUS FORMATION WAS NOTICED AROUND THE FRACTURE, ALTHOUGH IT WAS DIFFICULT TO TELL IF COMPLETE. 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. WE DO NOT HAVE THE OPPORTUNITY TO IDENTIFY INDIVIDUAL HCPS AND REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 16014170 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM INFLAMMATORY REACTION AROUND THE DEVICES AFTER HAVING A FRACTURE FIXATION SURGERY OF THE LEFT FEMUR USING THE TRIGEN RETROGRADE FEMORAL NAIL SYSTEM. THE PATIENT UNDERWENT AN UNPLANNED HARDWARE REMOVAL ON (B)(6) 2017. THE PATIENT ACHIEVED UNION AT 27 WEEKS AFTER THE PRIMARY SURGERY. 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. WE DO NOT HAVE THE OPPORTUNITY TO IDENTIFY INDIVIDUAL HCPS AND REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Inflammation; Pain

  MAUDE report 16010542 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TRAUMA SURGERY PERFORMED ON 2021, THE PATIENT PRESENTED NON-UNION. A REVISION SURGERY WAS PERFORMED TO EXCHANGE FROM META RETRO FEM NAIL 11.5 X 40 WITH TWO TRIGEN LOW PROFILE SCREW 5.0MM X 32.5MM TO A LARGER META NAIL RETROGRADE. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15256384 ↗