TRIGEN 71674576Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556363447), received between Dec 5, 2020 and Feb 8, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TRAUMA TREATMENT, ONE (1) TRIGEN T-HANDLE BROKE AT THE POINT WHERE INSTRUMENTS ARE INSERTED, AND IT DOES NOT MAINTAIN PROPER ATTACHMENT TO INSTRUMENTS THAT ARE INSERTED. THE TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288375 ↗
• MalfunctionApr 25, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TRIGEN T-HANDLE BROKE. NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192481 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE CONNECTING PART ON THE TRIGEN T-HANDLE WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161693 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT, THE TIP OF A TRIGEN T-HANDLE WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477969 ↗
• MalfunctionSep 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE TIP OF A TRIGEN T-HANDLE WAS FOUND BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455099 ↗
• MalfunctionSep 10, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF A TRIGEN T-HANDLE IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455066 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED THAT ONE TRIGEN T-HANDLE HAS A BROKEN TIP. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450899 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF A TRIGEN T-HANDLE BROKE AFTER PROCEDURE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447411 ↗
• MalfunctionJul 7, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT A TRIGEN T-HANDLE WILL NOT CONNECT. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132790 ↗
• MalfunctionMay 31, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY WHILE THE INSTRUMENTS WERE INSIDE OF THE PATIENT, THE LAG SCREW DRIVER (B)(4) CAPTURE STICK CAUGHT ONTO A GUIDE PIN AND SEEMED TO BE DEFECTIVE; THE PIECE ON THE T-HANDLE (B)(4) WAS BROKEN IN THE CAPTURES OF THE SCREWDRIVER. THERE WERE NO PIECES BROKEN OFF INSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909921 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TRIGEN T-HANDLE BROKE OUTSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED. 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 11904856 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TRIGEN T-HANDLE BROKE OUTSIDE THE PATIENT. 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 11842156 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TRIGEN T-HANDLE BROKE OUTSIDE THE PATIENT. 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 11821004 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE A TRIGEN T-HANDLE BROKE. INSTRUMENT 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 11816869 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE TRIGEN T-HANDLE BROKE OUTSIDE THE PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816846 ↗
• MalfunctionApr 11, 2021Connection Problem; Connection Problem

  ((B)(4)) IT WAS REPORTED THAT DURING INSPECTION PROCESS, IT WAS FOUND THAT THE THREADS ON THE LAG SCREW DRIVER ARE BENT. THERE WAS NO CASE INVOLVED. ((B)(4)) IT WAS REPORTED THAT DURING INSPECTION PROCESS, IT WAS FOUND THAT THE TRIGEN T-HANDLE DOES NOT CAPTURE AND RELEASE DRIVER PROPERLY. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646832 ↗
• MalfunctionMar 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, A NEW PACKAGED WITH A TRIGEN T-HANDLE WAS OPENED AND IT WAS FOUND THAT THE INSTRUMENT RATTLES, LIKE SOMETHING IS LOSE. IT WAS NOTICES THE 2 BALL BEARINGS MOVING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541734 ↗
• MalfunctionDec 5, 2020Crack; Connection Problem; Crack; Connection Problem

  IT WAS REPORTED THAT THE T HANDLE IS NOT LOCKING AND HAS TWO CRACKS. IT IS UNKNOWN IF THERE WAS ANY DELAY, ANY HARM OR INJURY. IT IS ALSO UNKNOWN HOW THE PROCEDURE WAS FINISHED AND WHEN IT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10951137 ↗