ASNIS 604646SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540089823), received between Feb 27, 2019 and Mar 28, 2023 — classified as 2 malfunctions.

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

• MalfunctionMar 28, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE ASNIS 4.0 WAS BROKEN DURING REMOVAL SURGERY. THE DOCTOR ATTEMPTED TO REMOVE THE BROKEN SCREW USING THE EXTRACTOR FOR 4.0 MM DIAMETER IN THE ASNIS 4.0 EXTRACTION SET, BUT THE TIP OF THE EXTRACTOR WAS ALSO BROKEN (CHIPPED). THE BROKEN EXTRACTOR TIP WAS REMOVED EVENTUALLY. HOWEVER, ONLY THE HEAD OF THE SCREW COULD BE REMOVED AND THE DOCTOR CLOSED SURGICAL INCISION WHILE THE THREAD PART OF THE SCREW WAS LEFT IN THE PATIENT'S BODY. ONLY THE SHAFT OF THE EXTRACTOR WILL BE RETURNED FROM THE FACILITY. BROKEN TIP OF THE EXTRACTOR AND HEAD OF THE SCREW WERE DISPOSED AT THE HOSPITAL AFTER REMOVAL.".

  Patient problems: Foreign Body In Patient

  MAUDE report 16628349 ↗
• MalfunctionFeb 27, 2019Fracture

  IT WAS REPORTED THAT ON (B)(6) 2017, VARIAX FIBLA PLATE AND ASNISS4.0 SCREW WERE IMPLANTED FOR RIGHT ANKLE JOINT. AT (B)(6) 2019, ALTHOUGH ALL DEVICES WERE TRIED TO BE REMOVED BECAUSE BONE FUSION WAS CONFIRMED, THE SCREW WAS FRACTURED ABOUT 5MM FROM THE BASE OF SCREW HEAD. THEREFORE, THE ASNISS SCREW WAS LEFT IN THE PATIENT BODY. THE SCREW WAS REMOVED WITH SOLID DRIVER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8375084 ↗