ASNIS 325046SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327076196), received between Jun 17, 2020 and Jun 20, 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 18, 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.

• MalfunctionJun 20, 2023Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING REMOVAL OF THE SCREW, THE MATERIAL GRADUALLY PROGRESSIVELY TWISTED AND THEN DISINTEGRATED IN THE PATIENT PREVENTING THE COMPLETE REMOVAL OF THE DEVICE. THE DOCTOR BROKE THE SCREW AS CLOSE TO THE BONE AS POSSIBLE AND IT IS DISTAL ENOUGH NOT TO INTERFERE WITH A FUTURE TOTAL KNEE REPLACEMENT. THIS RESULTED IN A 30 MINUTE SURGICAL DELAY AND THERE WILL BE NO NEED TO SCHEDULE ANOTHER SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17161252 ↗
• MalfunctionJun 17, 2020Fracture; Fracture

  PRIMARY PROCEDURE, ELBOW FRACTURE. IT WAS REPORTED THAT WHEN MANUALLY IMPLANTING THE 4.0 CANNULATED SCREW, THE SURGEON FELT THE SCREW SNAP WHEN IT WAS APPROXIMATELY HALFWAY IMPLANTED. INTRA-OPERATIVE IMAGING SHOWED THAT THE PORTION IN THE PATIENT'S BONE WAS SHATTERED. THE SURGEON REMOVED AS MANY OF THE PIECES AS HE COULD. ONE SMALL PIECE REMAINED IN THE PATIENT AND IS TRAPPED IN WITH THE SECOND IMPLANTED CANNULATED SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 45 MINUTES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10161992 ↗