TRIGEN 71637342Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010441225), received between Feb 9, 2022 and Feb 9, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 9, 2022Break; Fracture; Product Quality Problem; Break; Fracture; Product Quality Problem

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY FOR A SUB-TROCHANTERIC FRACTURE, WHEN INSERTING THE TAN LIME 11.5X42 LF IN THE PATIENT'S MEDULLARY CANAL, THE DRILL BIT WENT OUT OF THE NAIL HOLE AND BROKE INSIDE THE PATIENT. THERE WAS A DELAY OF GREATER THAN 2 HOURS, WHILE THE END-USER TRIED TO REMOVE THE BROKEN PART, BUT IT WAS DIFFICULT AS IT WAS IN THE NECK OF THE FEMUR. HE HAD ALREADY SPENT A LONG TIME TRYING IN S+N TAN NAIL, SO HE DECIDED TO KEEP THE BROKEN PART AND FINISHED USING A COMPETITOR'S DEVICE. NO PATIENT HARM REPORTED, THE CURRENT HEALTH STATUS IS GOOD, AND THE FRACTURE HAS BEEN HEALING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13498826 ↗

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