NA 214.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982153494), received between Jul 31, 2018 and Jul 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.

• MalfunctionJul 31, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A STAINLESS STEEL DYNAMIC HIP SCREW (SSDHS) SURGERY ON (B)(6) 2018, THE CORTEX SCREW BROKE WHILE THE SURGEON WAS TIGHTENING IT. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. A NEW SCREW OF SAME SIZE WAS USED TO MANAGE THE PROBLEM DURING THE PROCEDURE. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREWDRIVER (PART/LOT UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7734697 ↗