ASNIS 604640SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540089762), received between Jul 12, 2023 and Feb 18, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT : "A SCREW FROM THE ASNIS III RANGE BECAME DEFORMED AND EVENTUALLY BROKE AT THE HEAD DURING ABLATION ON A 14-YEAR-OLD PATIENT, MAKING ABLATION IMPOSSIBLE." MEASURES/ACTIONS TAKEN TO COMPLETE THE PROCEDURE: BREAK THE SCREW FLUSH WITH THE CORTEX AND LEAVE THE REMAINING PART IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21404011 ↗
• InjuryFeb 18, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023. BONE FUSION WAS ACHIEVED AND REVISION SURGERY FOR EXPLANTATION WAS PERFORMED ON (B)(6) 2025. THE HEAD OF ASNIS SCREW WAS DEFORMED WHEN REMOVING THE SCREW. SURGEON USED THE EXTRACTOR TO REMOVE THE DEFORMED SCREW, HOWEVER, THE TIP OF THE EXTRACTOR WAS BROKEN. SURGEON TRIED TO REMOVE THE SCREW WITH USING PLIERS, HOWEVER, THE HEAD OF SCREW WAS BROKEN AND THE SCREW COULD NOT BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21395639 ↗
• MalfunctionMay 6, 2024Inaccurate Information; Inaccurate Information

  AS REPORTED: "THEY OPENED A SCREW WHICH TURNED OUT TO BE A WASHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SIZE SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247792 ↗
• InjuryJul 12, 2023Break; Fracture; Break; Fracture

  SALES REP REPORTED THAT : "FOLLOWING A TTAT (TRANSPOSITION OF THE TUBEROSITY OF THE ANTERIOR TIBIA) ON A 16-YEAR-OLD ADOLESCENT (52KG), THE 2 ASNIS 4MM DIAMETER SCREWS BROKE." A REVISION SURGERY HAS BEEN PLANNED.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17304857 ↗