ASNIS 325060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327078039), received between Mar 28, 2019 and Nov 15, 2021 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2021Break; Material Fragmentation; Break; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE ASNIS III CANNULATED SCREW UNTHREADED AT TIP AND FRAGMENTS HAD TO BE RETAINED WITHIN BONE UPDATE : CUSTOMER REPORTED THAT DURING A ORIF ELBOW PROCEDURE, USING ASNIS III CANNULATED SCREW PARTIALLY THREADED 60MM, ONCE SCREW WITHIN BONE XRAYS WERE TAKEN TO ASSESS AND FOUND FOREIGN BODY AT TIP OF SCREW THAT LOOKED TO BE THREADING FROM SCREW. SCREW WAS REMOVED AND FOREIGN MATERIAL REMAINED WITHIN THE MEDULLARY CAVITY. AFTER EXAMINATION, IT WAS FOUND THAT THE TIP HAD UNTHREADED AND BROKEN OFF WITHIN THE BONE. ANOTHER SCREW OF THE SAME SIZE WASN'T AVAILABLE SO A SHORTER SCREW HAD TO BE SELECTED.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 12813447 ↗
• MalfunctionSep 4, 2020Fracture; Fracture

  CUSTOMER REPORTED : "THESE SCREWS WERE PLACED IN THE PATIENT ON (B)(6) 2019 AT THE LEVEL OF THE MEDIAL MALLEOLUS. THE TWO SCREWS WERE REMOVED ON (B)(6) 2020. THE FIRST SCREW WAS EXTRACTED WITHOUT ANY PROBLEM. HOWEVER, DURING THE EXTRACTION OF THE SECOND SCREW, THE PRE-THREADED AXIS TWISTED AND PREVENTED ITS REMOVAL. AN ATTEMPT WAS MADE TO EXTRACT THE SCREW WITH A STRONG PAIR OF PLIERS AND THEN WITH A TREPHINE, WHICH ALLOWED THE PRE-THREADED BONE CORE TO BE REMOVED WITHOUT ALLOWING THE SCREW TO BE REMOVED IN REVERSE. PART OF THE SCREW IS LEFT INTRAOSSEOUS."

  Patient problems: Debris, Bone Shedding; Device Embedded In Tissue or Plaque

  MAUDE report 10497075 ↗
• MalfunctionMar 28, 2019Fracture; Peeled/Delaminated; Detachment of Device or Device Component; Fracture

  CUSTOMER REPORTED A FRACTURE OF DISTAL HUMERUS. ANSIS 4.0MM CANNULATED SCREW IMPLANTED. DURING IMPLANTATION THE DISTAL THREADS OF THE SCREW APPEARED TO PEEL AWAY FROM THE CORE OF THE SCREW. LATERAL SIDE OF ELBOW OPENED TO REMOVE THREADS OF METAL TO COMPLETE THE CASE. X-RAYS SHOW A SMALL AMOUNT OF METAL REMAINING AFTER THE MAJORITY OF THE COILS WERE REMOVED. NO X-RAYS AVAILABLE FOR BEFORE ANY OF THE METAL COIL FRAGMENTS WERE REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461804 ↗