TRIGEN 71639315Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010462633), received between Aug 10, 2018 and Aug 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (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. 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.

• InjuryAug 10, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ONE OF OUR DISTRIBUTER MADE PO FOR TRIGEN TROCHANTERIC NAIL WITHOUT SPECIFYING SCREWS. OPERATION WAS STARTED TO USE TRIGEN KIT BUT AFTER DRILLING OF THE BONE AND PREPARING FEMUR AND NECK FOR THE OPERATION, OPERATOR AND SALES PERSONNEL REALIZED THAT THERE WAS NO RELATED SCREWS IN THE KIT FOR THIS REASON TRIGEN NAIL WAS REMOVED FROM THE PATIENT. OPERATION WAS COMPLETED WITH DIFFERENT BRAND NAIL KIT HOWEVER PATIENT BONE WAS HARMED AND FRACTURES WERE SEEN. NO SPECIFIC PRODUCT PROBLEM WAS REPORTED.

  Patient problems: Injury

  MAUDE report 7774561 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981529. One submission often covers many models, so check the product and lot details in each record.

• 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