ASNIS 325065SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327076295), received between Jul 1, 2020 and Jul 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2020Fracture; Fracture

  THE 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. UNFORTUNATELY, THE REFERENCE OF THE BROKEN SCREW COULD NOT BE PRECISELY IDENTIFIED (IT'S EITHER A DEBRIS FROM REF 325065S OR FROM REF 325060S).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10217976 ↗