TRIGEN 71631160Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010419682), received between Feb 24, 2021 and Dec 29, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY ONE (1) 6.4MM DRILL BROKE IN HALF WHILE IN USE. NO PIECES FELL INSIDE THE WOUND. WHEN A BACK-UP TRAY WAS OPENED IT WAS NOTICED THAT ONE (1) 6.4MM DRILL WAS DULL . 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 23919167 ↗
• MalfunctionDec 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE 6.4MM DRILL SNAPPED IN HALF. NO PIECES FELL INSIDE THE WOUND. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK UP. ALTHOUGH, IT WAS NOTICEABLY DULL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877662 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, ONE (X1) 6.4MM DRILL BROKE DURING USE. 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 17618695 ↗
• InjuryDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING DRILLING AT THE FEMORAL HEAD, THE END OF ONE (1) 6.4MM DRILL BROKE. THE BROKEN PIECE COULD NOT BE REMOVED AND REMAINED IN THE BONE. HOWEVER, THERE WAS NO EFFECT ON THE INSERTION AND SCREWING OF THE PROXIMAL SCREWS. IT IS UNKNOWN WHETHER THERE WAS A DELAY OR HOW THE SURGERY WAS COMPLETED. PATIENT´S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16048662 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF A 6.4MM DRILL BROKE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809578 ↗
• MalfunctionFeb 24, 2021Corroded; Corroded

  IT WAS REPORTED THAT AFTER A PROCEDURE IT WAS FOUND THAT THE INSTRUMENT WAS RUSTED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376566 ↗

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