ASNIS 604636SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540089724), received between Apr 26, 2024 and Jan 20, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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

• InjuryJan 20, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING THE EXTRACTION OF ASNIS 4.0, THE EXTRACTION PROVED DIFFICULT DUE TO THE BONE QUALITY BEING FAVOURABLE. UPON USING THE EXTRACTOR, THE TIP OF THE EXTRACTOR BROKE OFF. THE ASINIS 4.0 COULD NOT BE REMOVED AND REMAINS IMPLANTED IN THE BODY. IT IS NOTED THAT FRAGMENTS REMAIN WITHIN THE BODY. THE PHYSICIAN BELIEVES THESE FRAGMENTS CAN BE REMOVED DURING THE ATTEMPTED RE-EXTRACTION OF THE ASNIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24115663 ↗
• MalfunctionApr 26, 2024Break; Fracture; Difficult to Remove; Break; Fracture; Difficult to Remove

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023. REVISION SURGERY FOR REMOVE THE IMPLANTS DUE TO BONE UNION COMPLETED ON (B)(6) 2024. DURING PROCEDURE, SCREW AND EXTRACTOR WAS FRACTURED AND REMAINED IN THE PATIENT BODY. THE SURGEON DECIDE TO REMAIN THESE PIECES IN THE PATIENT, PROCEDURE WAS COMPLETED."

  Patient problems: Foreign Body In Patient

  MAUDE report 19197477 ↗