TRIGEN 71631432Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556158395), received between Dec 7, 2020 and Jan 15, 2024 — classified as 2 injuries.

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 16, 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.

• InjuryJan 15, 2024Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THERE WAS A LOT OF RESISTANCE IN THE BONE AND THE META-TAN LAG SCREW DRILL FAILED TO ADVANCE. THE SALES REP ADVISED SURGEON TO STOP AS THE TIPS OF THE DRILL FLARED OUT ON THE X-RAY. WHEN THE SURGEON TRIED TO REVERSE THE DRILL, IT SNAPPED OFF IN THE PATIENT'S FEMUR NECK. THERE WAS NO WAY TO CONTINUE THIS STEP OR REMOVE THE DRILL, FOR WHICH THEY PROCEEDED TO COMPLETE THE OPERATION WITHOUT INSERTING THE LAG SCREW. EVEN THOUGH THE SURGEON ATTEMPTED ADDITIONAL FIXATION WITH A STD LOCKING MODE, THE FIXATION DID NOT HOLD AND THE PATIENT WAS TAKEN FOR A REVISION WITH NEW INSTRUMENTATION 3 DAYS LATER. THE BROKEN PIECES CANNOT BE RETRIEVED AND ARE STILL IN THE PATIENT'S FEMUR NECK. PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 18510513 ↗
• InjuryDec 7, 2020Break; Break

  IT WAS REPORTED THAT DURING A META TAN PROCEDURE, THE ENTRY COMP REAMER BROKE DURING USE INSIDE OF THE PATIENT. ALL OF THE PIECES WERE RECOVERED. SUBSEQUENTLY, THE MAIN COMP SCREW REAMER WOULD NOT FIT AND THE LAG REAMER WAS USED. THE LAG REAMER WAS FUNCTIONING BUT NOT AS SMOOTHLY. THERE WAS A DELAY OF LESS THAN 30 MINUTES DUE TO THIS ISSUE. NO OTHER COMPLICATIONS WERE REPORTED. THE INVESTIGATION FOUND THAT THE META-TAN LAG SCREW DRILL WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10959282 ↗

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