TRIGEN 71655137Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010585592), received between Dec 19, 2022 and Oct 9, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PERSISTENT DRAINAGE AND REDNESS AROUND A PREVIOUSLY CLOSED INCISION OF LEFT ANKLE AFTER HAVING A FRACTURE FIXATION SURGERY OF THE LEFT TIBIA USING THE TRIGEN TIBIAL META-NAIL SYSTEM. TO TREAT THIS CONDITION THAT PATIENT SUSTAINED AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2017. THE PATIENT WAS STABLE AND DISCHARGED HOME. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Erythema; Fluid Discharge

  MAUDE report 20412900 ↗
• InjuryOct 9, 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 A SECOND UNPLANNED HARDWARE REMOVAL ON (B)(6) 2019. DURING THIS UNPLANNED SURGERY, ON THE TRIGEN TIBIAL META-NAIL SYSTEM, THE TRIGEN META TIBIAL NAIL 10MM X 37CM AS WELL AS TWO PROXIMAL INTERLOCKING SCREWS AND ONE REMAINING DISTAL INTERLOCKING SCREW WERE REMOVED. PRIMARY FIXATION SURGERY WAS PERFORMED ON (B)(6) 2016 AFTER A SERIOUS MOTOR VEHICLE ACCIDENT.

  Patient problems: Impaired Healing

  MAUDE report 20412809 ↗
• InjuryAug 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FIXATION SURGERY ON (B)(6) 2016 AFTER THE PATIENT SUSTAINING A MOTOR VEHICLE ACCIDENT. THE INDICATION FOR THIS FIXATION SURGERY WAS A LEFT DISTAL TIBIA FRACTURE, LEFT CLOSED DISTAL FEMUR FRACTURE AND LEFT OPEN SEGMENTAL TIBIA FRACTURE. THE PROCEDURES PERFORMED WERE TREATMENT OF LEFT TIBIA SHAFT FRACTURE WITH INTRAMEDULLARY DEVICE, OPEN TREATMENT OF DISTAL TIBIA INTRA-ARTICULAR FRACTURE WITH FIXATION OF TIBIA ONLY, MANUAL APPLICATION OF STRESS PERFORMED BY PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL FOR JOINT RADIOGRAPHY, LEFT ANKLE, RETROGRADE NAILING OF LEFT FEMUR, AND IRRIGATION AND DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE, MUSCLE AND BONE OF OPEN LEFT TIBIA FRACTURE. DURING THIS SURGERY AN UNSPECIFIED PLATING SYSTEM FROM SMITH AND NEPHEW WAS IMPLANTED, AS WELL AS A TRIGEN FEMORAL NAILING SYSTEM AND A TRIGEN TIBIAL NAILING SYSTEM. THE PATIENT SUFFERED FROM INFLAMMATORY REACTION AROUND THE DEVICES AFTER HAVING THE PRIMARY SURGERY AND 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 U

  Patient problems: Inflammation; Pain

  MAUDE report 20058825 ↗
• InjuryApr 13, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT AFTER A SURGERY WAS PERFORMANCE, ONE (1) META-NAIL TIBIAL 10MM X 37CM WAS REQUIRED TO BE REMOVED DUE TO NON-UNION IN A REVISION SURGERY. THE NAIL WAS REPLACED WITH A META-NAIL. NO INJURY TO PATIENT WAS REPORTED. PATIENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735038 ↗
• MalfunctionDec 23, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A ROCK WAS FOUND WITHIN THE META-NAIL TIBIAL 10MM X 37CM WHEN OPENED. IT IS UNKNOWN HOW SURGERY WAS FINISHED AND IF IT WAS DELAYED; HOWEVER, PATIENT HARM WAS NOT INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043354 ↗
• 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 IMPLANT SECTION AFTER HAVING A FRACTURE FIXATION SURGERY OF THE LEFT TIBIA USING THE TRIGEN TIBIAL META-NAIL SYSTEM. THE PATIENT UNDERWENT AN UNPLANNED HARDWARE REMOVAL. ON (B)(6) 2017, TWO MEDIAL TO LATERAL INTERLOCKING SCREWS WERE REMOVED, FOLLOWED BY THE 2.7 MM SCREW ACROSS THE PLAFOND. IM NAIL WAS REMOVED ON (B)(6) 2019. THE PATIENT ACHIEVED UNION AT 35 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: Bacterial Infection; Fluid Discharge; Impaired Healing; Inflammation; Osteomyelitis; Pain

  MAUDE report 16010440 ↗