TRIGEN 71645037Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556215746), received between Apr 21, 2018 and Sep 20, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K111025, K161264, K210980); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2020 TO TREAT AN TROCHANTERIC FRACTURE, THE PATIENT EXPERIENCE THE BREAKAGE OF ONE OF THE DISTAL INTERLOCKING SCREWS AS CONFIRMED WITHIN THE NOTES OF A FOLLOW UP CONDUCTED IN OR AROUND (B)(6) 2020. NO OTHER COMPLICATION FEATURES WERE REPORTED AS PART OF THE CLINICAL COURSE OF THIS PATIENT, BUT ANY SPECIFIC MEASURES TAKEN TO ADDRESS THE SCREW BREAKAGE WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 15459941 ↗
• InjuryFeb 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FRACTURE OF THE NECK OF THE FEMUR. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2022, REMOVING THE TRIGEN LOW PROFILE SCREW 5.0MM X 37.5MM. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 13615101 ↗
• InjurySep 27, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN ON (B)(6) 2021. THIS ADVERSE EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2021. THE SURGEON DETERMINED THIS FAILURE WAS DUE TO A NON-UNION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12537484 ↗
• InjuryMay 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE NAIL WAS BROKEN DUE TO A NON UNION OF FRACTURE, AND THE DISTAL SCREW WAS ALSO BROKEN FOR WHICH A PROXIMAL FEMORAL REPLACEMENT AND TOTAL KNEE REPLACEMENT WAS CARRIED OUT. THE SURGEON DOES NOT BLAME THE PRODUCT FOR THE FAILURE.

  Patient problems: Injury

  MAUDE report 8624634 ↗
• InjuryApr 21, 2018Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT THE NAIL BROKE INSIDE THE BONE, PATIENT HAD INSTABILITY, SO A REVISION SURGERY WAS PERFORMED AND THE NAIL WAS REMOVED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7449510 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, K161264, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-1132-2013 · Mar 6, 2013 · Terminated
  TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery