RUSSELL-TAYLOR 110245Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010034441), received between Aug 20, 2020 and Apr 21, 2022 — classified as 1 injury, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K122170); 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 18, 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.

• MalfunctionApr 21, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TW DRL F/COLE RAD DRL 4.0 BROKE WHILE IN USE. THE METAL AND PLASTIC PART SEPARATED. INCIDENT OCCURRED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A 10 MINUTES DELAY, WITH A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176029 ↗
• InjuryAug 20, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING META TAN SURGERY, THE TWIST DRILL FOR COLE RADIOLUCENT DRILL 4.0 WOBBLED, AS SAME AS THE FIRST ONE, AND FAILED TO DRILL THE THIRD SCREW HOLE. THE PROCEDURE WAS FINISHED WITH A CHANGE IN SURGICAL TECHNIQUE, WITHOUT INSERTING/TIGHTENING THE THIRD SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT WAS NOT INJURED BEYOND WHAT HAS ALREADY BEEN DESCRIBED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10434286 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha