TRIGEN 71674034Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010560544), received between Feb 11, 2020 and Jul 12, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093047); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A 7.0MM COMPRESSION SCREW DRILL DID NOT RUN PARALLEL ONTO THE LAG SCREW DRIVER, RENDERING THE SURGEON UNABLE TO INSERT THE SCREW. THEREFORE, SURGEON HAD TO REMOVE THE ANTI-ROTATION BAR, TURN THE SCREW BACK COMPLETELY, AND THEN PULL ON THE ROD WITH FORCE BECAUSE IT WAS JAMMED IN THE SLEEVE OR IN THE FEMUR DUE TO THE INCORRECT DRILLING DIRECTION. IT IS UNKNOWN IF THIS INCIDENT CAUSED ANY DELAY. SURGERY WAS FINISHED WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE INSTRUMENTS WERE CHECKED LATER, AND NO ERROR WAS FOUND.

  Patient problems: Internal Organ Perforation; Perforation

  MAUDE report 14990942 ↗
• MalfunctionJul 1, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT AN INTERTAN 7.0MM COMPRESSION SCREW DRILL IS DULL DUE TO REPEATED USE AND REQUIRES REPLACING. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10218321 ↗
• MalfunctionFeb 11, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON WAS PERFORMING AN INTERTAN NAIL AND WHEN HE USED THE 7.0 COMPRESSION SCREW DRILL, THE TIP BROKE OFF. THE PIECES WERE RETRIEVED AND NOT LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9697060 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434