TRIGEN 71751139Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010515476), received between Mar 16, 2021 and Mar 4, 2025 — 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.

• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 3.2MM SHORT GRAD BRAD PT DRILL AND ONE (1) 3.2MM LONG GRAD BRAD PT DRILL WERE DULL. ALSO, ONE (1) 6.00MM FXD ENDCUTTING RMR AND ONE OF THE GUIDES ARE STUCK TOGETHER AND CANNOT BE SEPARATED. ADDITIONALLY, ONE (1) HUMERAL SCREW DEPTH GAUGE WAS BROKEN AT THE THREADED PART. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513254 ↗
• MalfunctionMar 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOCK SCREW OF A HUMERAL SCREW DEPTH GAUGE FELL OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925095 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING INSPECTION, TWO (2) HUMERAL SCREW DEPTH GAUGE, WERE NOT HOLDING THE SCREWS AND SPINNING IN THE HEADS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806083 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING INSPECTION, TWO (2) HUMERAL SCREW DEPTH GAUGE, WERE NOT HOLDING THE SCREWS AND SPINNING IN THE HEADS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806072 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT THE PIECE THAT ATTACHES THE INNER SLEEVE TO THE OUTER SLEEVE HUMERAL SCREW DEPTH GAUGE HAD BROKEN OFF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11497535 ↗

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