TRIGEN 71751126Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010514714), received between Sep 4, 2020 and Jan 11, 2022 — 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.

• MalfunctionJan 11, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT DURING AN INSPECTION THE HUMERAL RULER WAS SEEN TO HAVE FADED MARKINGS, SO THE NUMBERS COULD NOT BE READ. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13227338 ↗
• MalfunctionJan 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NAIL SURGERY THE INNER PIECE OF THE HUMERAL RULER DOES NOT STAY IN THE OUTER SLEEVE. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13145082 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS REPORTED THAT THREE UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), THE TIBIAL SPACER BLOCK STANDARD ((B)(6)) THE JOURNEY II XR TIBIAL BASE IMPLANT IMPACTOR ((B)(4)) AND THE JOURNEY UNI TIBIAL TRAIL INSERT SIZE 3-4/ 9 MM ((B)(4)) WERE NOTICED CRACKED. THE SCREW DEPTH GAUGE ((B)(4)), META-TAN ANTI ROTATION BAR ((B)(4)), HUMERAL RULER ((B)(4)), TWO SCREW DRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) THE JOURNEY II TKA FEMORAL TRIAL LEFT SIZE 5 ((B)(4)) AND 3.5 MM LOCKING SCREW GUIDE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593503 ↗
• MalfunctionNov 11, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT DURING SET UP INSPECTION THE HUMERAL RULER PRESENTED WEAR AND TEAR. THERE IS A CRACK FORMING ON THE SCREW ON COLLAR (BLACK PLASTIC PIECE). NO DELAY AND THE SAME DEVICE WAS USED. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. 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; No Patient Involvement

  MAUDE report 10824449 ↗
• MalfunctionSep 4, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE HUMERAL RULER BROKE EXTERNAL TO PATIENT. NO BROKEN PIECES FELL INSIDE THE PATIENT'S WOUND. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497547 ↗

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