ASNIS 325044SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327076165), received between Apr 23, 2018 and May 18, 2022 — classified as 2 injuries, 2 malfunctions.

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 18, 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.

• MalfunctionMay 18, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT: "WHEN POSITIONING THE SCREW, THE OPERATOR NOTICES THAT THE SCREW IS BROKEN AT THE END, A PIECE OF THE SCREW REMAINS IN THE IN THE PATIENT'S ELBOW. IT IS IMPOSSIBLE FOR THE SURGEON TO REMOVE THIS PIECE. PIECE OF SCREW LEFT IN THE PATIENT'S ELBOW."

  Patient problems: Foreign Body In Patient

  MAUDE report 14427468 ↗
• InjuryApr 30, 2021Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE CUSTOMER REPORTED THAT: "THE SCREW HAS BROKEN OFF AT THE THREAD. FRAGMENT OF THE SCREW IN THE PATIENT. NEED FOR A NEW SURGICAL INTERVENTION. REPLACEMENT OF THE SCREW."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11756499 ↗
• MalfunctionJan 22, 2019Break; Fracture; Fracture

  THE HOSPITAL REPORTED THE FOLLOWING EVENT : "DURING AN OPERATION ON THE MALEOLE, WHEN THE SCREW WAS SCREWED IN, IT BROKE. THE PATIENT HAD NO CLINICAL CONSEQUENCES, ANOTHER SCREW WAS USED INSTEAD BUT THE DURATION OF THE PROCEDURE WAS EXTENDED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8269494 ↗
• InjuryApr 23, 2018Break

  THE CUSTOMER REPORTED THAT THE ASNIS III 4.0 (44 CM TL 15MM) BROKE INSIDE THE PATIENT¿S ANKLE.

  Patient problems: No Code Available

  MAUDE report 7452699 ↗