TRIGEN 71674084Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 03596010560810), received between Apr 8, 2019 and Apr 24, 2026 — classified as 3 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Break” (60 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAILING, THREE (3) SCREWDRIVER RELEASE HANDLE BROKE AND STRIPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988801 ↗
• MalfunctionJan 6, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ANTEGRADE FEMUR NAIL SURGERY, ONE (1) SCREWDRIVER RELEASE HANDLE HAD A BROKEN TIP, PREVENTING ITS PROPER USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985911 ↗
• MalfunctionJul 30, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) SCREWDRIVER RELEASE HANDLE WAS BROKEN AND WARPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665064 ↗
• MalfunctionDec 19, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY FOR A HIP FRACTURE, THE END OF A (1) SCREWDRIVER RELEASE HANDLE WAS BENT AND BROKE OFF WHILE TRYING TO GET THE CAPTURE OFF THE MEDIUM HEX DRIVER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20976886 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A SCREWDRIVER RELEASE HANDLE WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 19055720 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE END OF THE SCREWDRIVER RELEASE HANDLE GOT TWISTED AND BROKE OFF. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707229 ↗
• MalfunctionJan 15, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A SCREWDRIVER RELEASE HANDLE WAS TWISTED. ITEM IS BROKEN, AND NO LONGER FUNCTIONING AS EXPECTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 18514877 ↗
• MalfunctionMay 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A SCREWDRIVER RELEASE HANDLE BROKE OFF WHILE RELEASING THE MEDIUM HEXDRIVER SHAFT FROM THE SCREW. NO BROKEN PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947785 ↗
• MalfunctionDec 29, 2022Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, WHEN THE SURGEON USED THE SCREWDRIVER RELEASE HANDLE TO REMOVE THE DRIVER FROM THE DISTAL SCREW, THE DISTAL CONNECTION PART OF THE SCREWDRIVER RELEASE HANDLE BECAME DEFORMED AND BROKE, WHILE THE PROXIMAL CONNECTION PART ALSO BECAME DEFORMED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (2 MINUTES), USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16066906 ↗
• MalfunctionNov 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING USE, THE TIP OF A SCREWDRIVER RELEASE HANDLE BROKE OFF WHILE TRYING TO REMOVE A SCREW. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE: THEY DIDN'T USE THE LOCK ON FEATURE, JUST USED THE OUTER SHEATH AS A SCREWDRIVER. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740870 ↗
• MalfunctionOct 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT A SCREWDRIVER RELEASE HANDLE BROKE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610493 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING INSPECTION, IT WAS NOTICED THAT THE SCREWDRIVER RELEASE HANDLE END IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537813 ↗
• MalfunctionMay 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE FLATHEAD TIP OF THE SCREWDRIVER RELEASE HANDLE BROKE OFF WHILE TIGHTENING A SCREW FOR A META TIBIA NAIL. THE PIECE WAS SUCCESSFULLY RECOVERED. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403074 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED THAT A SCREWDRIVER RELEASE HANDLE IS BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287478 ↗
• MalfunctionApr 21, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING SURGERY, A SCREWDRIVER RELEASE HANDLE CRACKED AND THEREFORE CANNOT BE STERILIZED. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176980 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE SCREWDRIVER RELEASE HANDLE BROKE OFF OUTSIDE OF THE PATIENT WHEN IN USE TRYING TO TIGHTEN THE RETAINING ROD. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543035 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING A NAIL PROCEDURE, A SCREWDRIVER RELEASE HANDLE BROKE. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417931 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT DURING STERILE PROCESSING DECONTAMINATION, IT WAS NOTICED THAT THE SCREWDRIVER RELEASE HANDLE WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13403806 ↗
• InjuryDec 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY WHILE THE INSTRUMENTS WERE INSIDE THE PATIENT, THE OBTURATOR AND SCREWDRIVER RELEASE HANDLE WERE BROKEN, AND A COMPRESSION SCREW HEXDRIVER WAS STUCK IN THEIR LAG OF THE INTERTAN SET. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY; HOWEVER, PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953455 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT, THE TIP OF THE SCREWDRIVER RELEASE HANDLE WAS CHIPPED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917376 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT, FROM THE LISTED DEVICES, FOUR (4) HAD A FAULTY JOINT AND THE OTHER ONES WERE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868992 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A SCREWDRIVER RELEASE HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866331 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A SCREWDRIVER RELEASE HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866329 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A SCREWDRIVER RELEASE HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866225 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A SCREWDRIVER RELEASE HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866218 ↗

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