TRIGEN 71770824Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010514431), received between Nov 3, 2025 and Nov 3, 2025 — classified as 1 malfunction.

4 other recalls cover devices cleared under the same FDA submission (K032722, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A HUMERAL INTERNAL FIXATION SURGERY, THE DOCTOR BEGAN REAMING WITH THE 6MM REAMER, THEN HE SWITCHES TO THE 8MM REAMER, IT WAS NOT REAMING THE TOTALITY OF THE CANAL, ONLY A COUPLE OF MILLIMETERS BELOW THE LINE OF THE FRACTURE, BECAUSE THE BONE IS SHOWING RESISTANCE. HE THEN GOES BACK TO THE 7MM REAMER, BUT IT ALSO DOES NOT REAM THE TOTALITY OF THE CANAL. HE PROCEEDS TO IMPLANT THE HUMERAL NAIL 8/7MM X 24CM, BUT THE INSERTION IS DIFFICULT AND THE FRACTURE BEGAN TO OPEN. THE SURGEON ATTEMPTS TO HAMMER THE NAIL OUT. WHILE DOING SO, HE FRACTURED A HUMERAL GUIDE BOLT WRENCH AND DEFORMED THE HUMERAL NAIL DRILL GUIDE. SINCE IT WAS NOT POSSIBLE TO EXTRACT THE NAIL, THE SURGEON DECIDED TO FORCE THE NAIL WHICH FRACTURED THE MOST DISTAL ANTERIOR PART OF THE BONE. HE PROCEEDED TO MAKE THE DISTAL AND SUPERIOR BLOCKAGE. THE PROCEDURE WAS COMPLETED WITH THE SAME NAIL AND DELAYED 45 MINUTES, THEREFORE REQUIRED 45 MINUTES OF ADDITIONAL ANESTHESIA. CURRENT HEALTH STATUS OF THE PATIENT IS STABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture; Unspecified Tissue Injury

  MAUDE report 23450994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032722, 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