TRIGEN 71760816Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010514394), received between Mar 26, 2026 and Mar 30, 2026 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 16, 2026Open, Classified

   Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.

   Z-2456-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE PROX STR HUMERAL NAIL 8/7 X 16 HAD NO HOLES FOR SCREWS IN THE NAIL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717825 ↗
• MalfunctionMar 26, 2026Nonstandard Device

  IT WAS REPORTED THAT, BEFORE AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE DISTAL HOLES OF ONE (1) PROX STR HUMERAL NAIL 8/7 X 16 WERE MISSING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707072 ↗

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-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