TRIGEN 71118200Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 03596010436528), received between May 28, 2020 and May 18, 2026 — classified as 17 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Break” (65 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 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR FRACTURED. NO PIECES FELL IN THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (SWITCHING TO ANOTHER RETAILER). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211778 ↗
• MalfunctionApr 29, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT, BEFORE AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE DISTAL END OF ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR WAS OBSERVED TO HAVE A SLIGHT BEND OR BREAK, WHICH PREVENTED THE REAMER HEADS FROM ATTACHING AS DESIGNED. THE PROCEDURE WAS PERFORMED, 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 25024301 ↗
• MalfunctionFeb 13, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR FRACTURED WHILE REAMING AND REMOVING INSTRUMENT FROM BONE. NOTHING FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SMITH & NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332206 ↗
• MalfunctionFeb 10, 2026Fracture

  IT WAS REPORTED THAT, DURING A TRIGEN IM NAILING SURGERY, DURING REAMING ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR APPEARED TO HAVE SNAPPED THROUGH THE LAST SEGMENT ON THE REAMER SHAFT. NO PIECES FELL INSIDE OF THE PATIENT-S WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305954 ↗
• MalfunctionJan 9, 2026Fracture

  IT WAS REPORTED THAT, DURING A NAIL SURGERY, TWO (2) FLEXIBLE SHAFT W/CIR CONNECTOR BROKE. 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 24023676 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHEN THE SURGEON WAS REAMING, THE TOP OF ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR SNAPPED OFF. NO PIECES FELL INSIDE THE WOUND. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN EQUIVALENT S+N BACKUP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815781 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING A NAIL SURGERY, A FLEXIBLE SHAFT W/CIR CONNECTOR BROKEN DURING NORMAL USE. THE PROCEDURE WAS PERFORMED, 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 23699856 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY NAILING PROCEDURE, WHILE ATTEMPTING TO UNSCREW THE THREADED GUIDE, DUE TO THE PATIENT¿S BONE BEING VERY RIGID AND DENSE, ONE (1) FLEXIBLE SHAFT WITH CIR CONNECTOR BROKE DURING REAMING. THE BROKEN PIECES WERE COMPLETELY REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610452 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, TWO (2) FLEXIBLE SHAFT W/CIR CONNECTOR BROKE. THE PROCEDURE WAS COMPLETED, AFTER ANY DELAY, WITH AN EQUIVALENT S+N BACK UP. NO INJURY WAS REPORTED AS CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285759 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT DURING TRAUMA SURGERY ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR WAS BROKEN. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT 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 23016793 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY, WHILE PASSING THE FLEXIBLE SHAFT W/CIR CONNECTOR INTO THE CANAL FOR THE THIRD TIME, IT FRACTURED AT THE DISTAL END. NO BROKEN PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669069 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR BROKE DURING USE. NO PIECES FELL INSIDE THE WOUND. 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 22355162 ↗
• MalfunctionJun 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE REAMING THE CANAL, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR WAS NOTICED TO BE FRACTURED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22234948 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR BROKE IN HALF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22024842 ↗
• MalfunctionMay 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHILE SURGEON WAS REAMING, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR BROKE WHERE IT ATTACHED TO THE DRILL. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990779 ↗
• MalfunctionApr 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR SNAPPED WHILST IN USE AT THE JUNCTION WITH THE REAMER HEAD. NOTHING WAS LEFT INSIDE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21820156 ↗
• MalfunctionMar 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN THE FLEXIBLE SHAFT W/CIR CONNECTOR WAS REMOVED IT WAS FOUND TO HAVE FRACTURED IN ITS DISTAL PORTION, BUT WITHOUT BEING DISASSEMBLED FROM THE DEVICE, THEN NO PIECE FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548047 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR BROKE AT THE CONNECTION POINT. 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 21337327 ↗
• MalfunctionJan 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE FLEXIBLE SHAFT W/CIR CONNECTOR BROKE WHILE BEING USED. 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 21092212 ↗
• MalfunctionDec 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR APPEARED TO HAVE BROKEN. NO PIECES FELL INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING AN UNKNOWN COMPETITOR DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20838867 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING OSTEOSYNTHESIS SURGERY, WHILE THE PATIENT'S CANAL WAS BEING REAMED, 0.5 AT A TIME, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR FRACTURED IN ITS PROXIMAL PART, AS THE BONE BEGAN TO PUT UP A LOT OF RESISTANCE. NO PIECE FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558353 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR BROKE DURING USE IN THE SHAFT. NOTHING LEFT IN PATIENT. 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 20523994 ↗
• MalfunctionOct 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS PROCEDURE, WHEN THE MEDULLARY CANAL WAS BEING REAMED, THE FLEXIBLE SHAFT W/CIR CONNECTOR FRACTURED AT THE TIP. IT IS UNKNOWN IF ANY PIECES FELL INTO THE PATIENT. THERE WAS A NON-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 20360419 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE OSTEOSYNTHESIS PROCEDURE, THE FLEXIBLE SHAFT W/CIR CONNECTOR BROKE IN ITS PROXIMAL PART WHERE IT CONNECTS TO THE HUDSON ANCHOR. NO PIECES FELL INTO THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260714 ↗
• MalfunctionSep 5, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING SURGERY (OSTEOSYNTHESIS PROCEDURE), A FLEXIBLE SHAFT W/CIR CONNECTOR BROKE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152130 ↗