NA 210064Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010101723), received between Jul 14, 2019 and Nov 18, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORIF ANKLE PROCEDURE, THE BLADE AT THE TIP IN A SUPER-BITE PIN CUTTER CHIPPED, MAKING IT NOT USABLE. NO PIECES FELL IN PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705892 ↗
• MalfunctionNov 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORIF ANKLE PROCEDURE, THE BLADE AT THE TIP IN ONE (1) SUPER-BITE PIN CUTTER CHIPPED, MAKING IT NOT USABLE. NO PIECES FELL IN PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678544 ↗
• MalfunctionJul 14, 2019Break; Break

  IT WAS REPORTED THAT PIN CUTTER NO LONGER CUTS PINS, INSTRUMENT BROKEN DURING SURGERY. ALL PIECES WERE RECOVERED. DELAYED THE SURGERY 2 MINUTES, BUT SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787692 ↗

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