TRIGEN 71631428Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556158401), received between Jul 30, 2020 and Aug 3, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE COMPRESSION SCREW COULD NOT GO THROUGH THE NAIL. IT IS UNKNOWN WHETHER THE META-TAN DRILL GUIDE, THE META-TAN DROP, THE META-TAN COMP SCREW DRILL OR THE META-TAN COMP SCREW STARTER DRILL CAUSED THIS PROBLEM. A CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED TO COMPLETE THE PROCEDURE WITHOUT ANY DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271639 ↗
• InjuryAug 1, 2020Break; Break

  IT WAS REPORTED THAT DURING THE METATAN PROCEDURE, THE ENTRY OF THE REAMER WAS BROKE, INSIDE THE PATIENT. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. THERE WAS A CHANGE IN THE SURGICAL TECHNIQUE BECAUSE THE COMP MAIN REAMER DID NOT FUNCTIONAL UNTIL THE LAG REAMER WAS USED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10354131 ↗
• InjuryJul 30, 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 UNTIL LAG REAMER WAS USED. THERE WAS A DELAY OF LESS THAN 30 MINUTES DUE TO THIS ISSUE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10344576 ↗

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