TRIGEN 71631185Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010427199), received between Jan 4, 2021 and Jun 7, 2021 — classified as 5 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2021Corroded; Corroded

  IT WAS REPORTED THAT, UPON INSPECTION BEFORE A NAIL INTERNAL FIXATION SURGERY, CANNULATED IMPACTOR - LONG WERE NOTICED TO HAVE RUST ON THEM. NO CASE INVOLVED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953561 ↗
• MalfunctionJun 7, 2021Corroded; Corroded

  IT WAS REPORTED THAT, UPON INSPECTION BEFORE A NAIL INTERNAL FIXATION SURGERY, CANNULATED IMPACTOR - LONG WERE NOTICED TO HAVE RUST ON THEM. NO CASE INVOLVED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953559 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A META-TAN DRILL GUIDE, A PERCUTANEOUS GUIDE BOLT, AND A CANNULATED IMPACTOR - LONG BROKE. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. IT IS UNKNOWN IF SURGERY WAS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885882 ↗
• MalfunctionMar 28, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHILE USING A CANNULATED IMPACTOR - LONG, OUTSIDE THE PATIENT, IT WOULD NOT DISENGAGE WITH THE DISPOSABLE EXTRACTOR. META NAIL CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580341 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT, THE CANNULATED IMPACTOR BROKE DURING SURGERY, OUTSIDE OF THE PATIENT. 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 11114997 ↗

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