TRIGEN 71631172Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010425096), received between Apr 11, 2021 and Jan 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K093047); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, ONE (1) T-HANDLE SNAPPED OFF FROM THE CORKSCREW AS FEMORAL HEAD WAS BEING REMOVED FROM THE PATIENT. 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 24229051 ↗
• MalfunctionJan 15, 2024Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION ONE (1) T-HANDLE CRACK. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAYED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511145 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT A T-HANDLE BROKE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625219 ↗
• MalfunctionJan 25, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING A NAIL PROCEDURE, THE T-HANDLE CRACKED OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353157 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT ONE T-HANDLE BROKE DURING AN UNKNOWN PROCEDURE. NO HEALTH CONSEQUENCES WERE REPORTED. FURTHER INFORMATION TO BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544679 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE 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 11901442 ↗
• MalfunctionMay 20, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING AN INSPECTION, IT WAS FOUND THAT THE T-HANDLE WOULD NOT SEPARATE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860144 ↗
• MalfunctionMay 13, 2021Corroded; Corroded

  IT WAS REPORTED THAT, DURING INSPECTION OR SET UP BEFORE A TRAUMA SURGERY, THE T-HANDLE SPRINGS WERE NOTICED TO BE RUSTY AND NEED TO BE REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817303 ↗
• MalfunctionMay 13, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING SET UP FOR AN INTERNAL FIXATION SURGERY, THE SPRINGS OF A T-HANDLE WERE RUSTY AND ITEM WAS UNABLE TO BE CLEANED. 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 11816888 ↗
• MalfunctionMay 6, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE T-HANDLE BROKE AND TORQUED OUTSIDE OF 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 11784730 ↗
• MalfunctionApr 11, 2021Break; Break

  IT WAS REPORTED THAT, IT WAS NOTED DURING PROCESSING THAT THE LOCKING MECHANISM TABS WERE BROKEN OFF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646847 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434