TRIGEN 71631124Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010419606), received between Sep 1, 2020 and Jun 7, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING SET UP FOR AN INTERNAL FIXATION SURGERY, THE REDUCER WAS NOTICED TO HAVE RUST ON IT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953422 ↗
• MalfunctionJun 3, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING SET UP FOR AN INTERNAL FIXATION SURGERY, THE REDUCERS WERE NOTICED TO HAVE RUST ON THEM. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935473 ↗
• MalfunctionJun 3, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING SET UP FOR AN INTERNAL FIXATION SURGERY, THE REDUCERS WERE NOTICED TO HAVE RUST ON THEM. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935451 ↗
• MalfunctionJun 3, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING SET UP FOR AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE REDUCER HAD RUST ON IT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935345 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE REDUCER BROKE DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11115026 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE REDUCER BROKE OUTSIDE OF THE PATIENT. NO INJURIES OR SURGICAL DELAYS WERE REPORTED. AN S+N BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10479695 ↗

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