ENDER NAIL 224035Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010105059), received between Aug 26, 2020 and Nov 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ACL SURGERY, IN A 4.0MM DIA NAIL 4.0MMX35CM, THE CLAMP BROKE WHILE SUTURING THE CUFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18141207 ↗
• MalfunctionAug 26, 2020No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT, 4.0MM DIA NAIL 4.0MM X 35CM DIDN'T WORK DURING SURGERY. IT WAS A DELAY DURING SURGERY GREATER THAN 30 MINUTES. THE PROCEDURE FINISHED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10457259 ↗