NA 02.206.224Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982051028), received between Aug 31, 2018 and Aug 31, 2018 — 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.

• MalfunctionAug 31, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A DISTAL TIBIAL FRACTURE REDUCTION ON (B)(6) 2018, A CORTEX SCREW BROKE UPON INTRODUCING THE SCREW INTO A DIAGONAL FORCE TO GENERATE SCREW AXIS. SURGICAL OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.5MM CORTEX SCREW/LOW PROFILE HEAD SELF-TAPPING/STAR DRIVE/24MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837382 ↗