NA 206.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982147387), received between Mar 31, 2026 and Mar 31, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMar 31, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A DISTAL TIBIAL MEIDAL MALLEOLAR FRACTURE FIXATION PROCEDURE, THE SURGEON WAS INSERTING A 4.0MM CANCELLOUS BONE SCREW. DURING FINAL TIGHTENING, THE HEAD OF THE SCREW FRACTURED AND SEPARATED FROM THE SHAFT. ATTEMPTS TO REMOVE THE REMAINING SHAFT WITH A BROKEN SCREW REMOVAL SET WERE UNSUCCESSFUL AFTER APPROXIMATELY 20 MINUTES, RESULTING IN THE DISTAL TIP OF THE BROKEN SCREW PROTRUDING ABOUT 2 MM AT THE DISTAL END OF THE MEDIAL MALLEOLUS. THE SURGERY WAS DELAYED BY ABOUT 20 MINUTES BUT WAS ULTIMATELY COMPLETED. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, SPECIFICALLY THE USE OF A SCREW REMOVAL SET. TWO SCREWS OF THE SAME TYPE WERE USED IN THE PROCEDURE, AND THE REDUCTION WAS REPORTED AS SATISFACTORY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24745138 ↗