TRIGEN 71674074Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010560704), received between Jun 16, 2020 and Mar 23, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE DOCTOR FOUND IT NECESSARY TO HAMMER A HONEYCOMB, IN VIEW OF CALCIFICATION IN THE MEDULLARY CANAL, AND TO HELP THE CANNULA ENTRY, BUT THE "T" OF THE HONEYCOMB BROKE. THE BROKEN PARTS WERE NOT REMOVED, AS SURGEON'S REQUEST. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16607575 ↗
• MalfunctionApr 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A 3.2MM T-HANDLE TROCAR WAS SNAPPED IN HALF. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14225471 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE 3.2MM T-HANDLE TROCAR BROKE. INCIDENT OCCURRED WHILE INSTRUMENT WAS OUTSIDE THE PATIENT AND NO PIECES FELL INTO THE INCISION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800979 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE HANDLE BROKE OF FROM THE BODY OF THE T-HANDLE TROCAR, WHILE WAS BEING USED OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642772 ↗
• MalfunctionNov 6, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE 3.2MM T-HANDLE TROCAR WAS FOUND INSIDE THE TRAY BROKEN AT THE BASE OF THE HANDLE. THERE WAS NO CASE INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10804834 ↗
• MalfunctionJun 16, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING CLEANING PROCESS, HANDLE WELD CAME APART AND SEPARATED. THE SHAFT CAME APART FROM THE HANDLE. NO ISSUES DURING CASE SINCE THE EVENT OCCURRED AFTER PROCEDURE. THEREFORE, NO DELAY AND NO BACKUP WAS NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10160242 ↗