TRIGEN 71642230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010464989), received between Jan 6, 2021 and May 17, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fitting 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. How this data works · Data updated Oct 13, 2026.

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.

• InjuryMay 17, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY. WHEN PLACING THE INT HEX CAP SCR 5.0 MM X 30 MM, IT WAS FOUND THAT IT WAS VERY SHORT AND THE DOCTOR DECIDED TO CHANGE IT FOR A LONGER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11833310 ↗
• MalfunctionJan 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, WHILE OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE THREAD ON THE TRIGEN INTERNAL HEX CAPTURED SCREW 5.0MM X 30MM IS FAULTY WITH A FRACTURED APPEARANCE. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW, WITH A DELAY OF LESS THAN 30 MINUTES, AND NO INJURY. PATIENT'S CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123828 ↗

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