Trigen 71935419Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556649626), received between Jan 2, 2021 and Aug 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Break; Fracture; Material Twisted/Bent; Break; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) TRIGEN EXT FLEXIBLE REAMER SHAFT 65CM TORQUED AND BROKE. 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 22710675 ↗
• MalfunctionJan 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TIBIA NAIL, THE TRIGEN EXT FLEXIBLE REAMER SHAFT 65CM BROKE IN HALF AS IT WAS BEING INSERTED INTO THE TIBIA CANAL OVER THE GUIDE WIRE. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A S+N BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195772 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT, A TRIGEN EXT FLEXIBLE REAMER SHAFT 65CM BROKE IN TWO PIECES. IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942658 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION FOR A TIBIAL NAIL CASE, THE TIP OF A EXTENDED FLEXIBLE REAMER SHAFT WAS FOUND DAMAGED AND NEEDS TO BE REPLACED. PROCEDURE WAS PERFORMED WITH A BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742459 ↗
• MalfunctionApr 22, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE REAMER SHAFT OF A TRIGEN EXT FLEXIBLE REAMER SHAFT 65CM BROKE OUTSIDE OF THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711046 ↗
• MalfunctionJan 13, 2021Crack; Crack

  IT WAS REPORTED THAT, A TRIGEN EXT FLEXIBLE REAMER SHAFT 65CM WAS SEEN TO BE CRACKED. INCIDENT OCCURRED DURING INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168538 ↗
• MalfunctionJan 2, 2021Break; Break

  IT WAS REPORTED THAT A LONG FLEXIBLE SHAFT REAMER BROKE DURING STERILIZATION PROCESS. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103620 ↗