NA 702624Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540112873), received between Oct 4, 2021 and Nov 30, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 30, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE KEY BROKE WHEN TRYING TO REMOVE IT FROM THE SCREW INSIDE THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING IF ANY DEBRIS WAS LEFT BEHIND IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15886400 ↗
• MalfunctionOct 4, 2021Device Difficult to Setup or Prepare; Difficult to Remove; Device Difficult to Setup or Prepare; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2020 AN EXPLANTATION WAS PERFORMED ON A PATIENT WHO UNDERWENT OSTEOSYNTHESIS WITH 3 AZNIS 6.5MM. THE SURGEON ATTEMPTED TO REMOVE THE SCREW WITH A SPECIAL SCREWDRIVER, BUT THE SCREWDRIVER WOULDN'T TURN BECAUSE THE PATIENT'S BONE QUALITY WAS GOOD. TWO SCREWS WERE REMOVED, BUT ONE COULD NOT BE REMOVED AND REMAINED IN THE BODY. THE SURGEON ATTEMPTED TO REMOVE THE SCREW WITH ANOTHER INSTRUMENT; HOWEVER IT COULD NOT BE REMOVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568349 ↗