TRIGEN 71634010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010495723), received between Nov 11, 2020 and Nov 14, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K210980, K981529); 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. 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.

• InjuryNov 14, 2022Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY (ACL OR OTHER) / TIBIA OSTEOSYNTHESIS, WHEN THE LOCKING SCREW WAS PLACED, IT WAS IMPOSSIBLE TO INSERT IT IN THE NAIL CAP 10MM. THEY PROCEEDED TO PERFORM DIFFERENT MANEUVERS TO INSERT THE PLUG BUT IT WAS NOT POSSIBLE, DYNAMIC LOCKING SCREW WAS NOT PLACED, WHICH WAS NOT A CAUSE THAT PREVENTED THE INSERTION OF THE PLUG. THE PROCEDURE COULD NOT BE COMPLETED, AFTER A NON-SIGNIFICANT DELAY (15 MINUTES). PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM, PATIENT'S HEALTH STATUS IS STABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789216 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED ON 2008, THE PATIENT SUFFERED A PERIPROSTHETIC FRACTURE AFTER A FALL. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, WHERE THE 11.5 X 38 130 D TAN RT ROSE, THE NAIL CAP 10MM AND TWO (2) UNKNOWN TRIGEN TAN/FAN NAIL SCREW WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Fall; Hip Fracture

  MAUDE report 15108944 ↗
• MalfunctionFeb 2, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING TIBIA'S OSTEOSYNTHESIS SURGERY THE TIBIAL NAIL WAS PLACED WITH A STATIC LOCKING TO PUT THE NAIL CAP 10MM ACCORDING TO THE SURGICAL TECHNIQUE. THE NAIL CAP 10MM WAS PASSED, IT WAS INSERTED INSIDE THE NAIL AND IT WAS NOT FIXED, IT WAS TRIED SEVERAL TIMES UNDER INTENSIFIER AND FINALLY, THE THREAD WAS OBSERVED WITH DAMAGE, WHICH PREVENTED FROM THE BEGINNING THE FIXATION OF THE CAP TO THE NAIL. THE DOCTOR DECIDED NOT TO PUT ANOTHER ONE AND FINISH THE PROCEDURE. NO REPORTED DAMAGE CAUSED TO THE PATIENT OR SIGNIFICANT DELAY. HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13429607 ↗
• InjuryJun 4, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, AT THE END OF THE TRAUMA PROCEDURE, THE NAIL CAP 10MM WAS PLACED ON THE PATIENT, BUT THIS DEVICE NEVER ENTERED. IT WAS WELL DISSECTED AND THE ENTRY OF THE NAIL WAS OBSERVED AND IT WAS ENTERED WITH GOOD DIRECTION, BUT IT WAS ROLLED AND IT ROLLED AND DID NOT ENTER. AFTER SEVERAL ATTEMPTS IT WAS NOT POSSIBLE TO PLACE THE CAP SO IT WAS ROLLED, IT WAS EVIDENCED IN THE IRREGULAR LINES. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS GREATER THAN 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942340 ↗
• InjuryNov 11, 2020Crack; Crack

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE TIBIAL INTRAMEDULLARY NAIL WAS FINALLY PUT ON THE NAIL CAP, THERE WAS A PROBLEM WITH THE THREAD OF THE NAIL CAP, WHICH COULD NOT BE SCREWED IN. WHEN THE THIRD NAIL CAP WAS REPLACED, IT WAS DIRECTLY STUCK WITH THE DRIVER AND COULD NOT BE REMOVED, AND IT CRACKED WHEN IT WAS JUST SCREWED IN. SURGERY WAS COMPLETED WITH AN S+N BACKUP DEVICE. NO INFORMATION ABOUT INJURIES OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10826156 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210980, K981529. 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-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• 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-0944-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for
• Z-0943-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for