Asnis 40-30118SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540533616), received between Apr 4, 2023 and Apr 4, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE IMPLANT SNAPPED/BROKE AND IS PROTRUDING TO THE SIDE OF HER TOE AND SHE WILL NEED A REVISION. PATIENT IS VERY WORRIED ABOUT GOING IN AND THEY HAVE NOT SEEN ANY PHYSICIANS YET. PATIENT NOTICED THIS BREAKAGE A YEAR OR TWO AGO. PATIENT STARTED NOTICING DISCOMFORT AND PROTRUDING OF IMPLANT THIS YEAR. PATIENT FOLLOWED ALL MOBILITY INSTRUCTIONS AND RESTRICTIONS THAT WERE PROVIDED TO BY THE SURGEON POST OP. REDDISH INFLAMMATION AROUND THE AREA WHERE PROTRUDED IMPLANT IS NOTICEABLE. THE TOE IS BENT SIDEWAYS TOWARDS THE BIG TOE, 2ND TWO FROM THE BIG TOE".

  Patient problems: Deformity/ Disfigurement; Discomfort; Failure of Implant; Implant Pain; Inflammation; Unspecified Infection

  MAUDE report 16678072 ↗