NA 204.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982145451), received between Mar 6, 2018 and Mar 9, 2018 — classified as 2 malfunctions.

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 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.

• MalfunctionMar 9, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 3.5 MM CORTEX SCREW IS DEFECTIVE. THE CUSTOMER NOTICED THAT THE SCREW WAS DEFORMED SOMEWHAT AT THE DISTAL END. THE ISSUE WAS IDENTIFIED WHEN THE CUSTOMER PULLED THE SCREW FROM THE TRAY BEFORE THE ONSET OF THE TPLO PROCEDURE. HENCE, THERE WAS NO IMPACT ON THE SURGERY OR THE PATIENT. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7327145 ↗
• MalfunctionMar 6, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, WHILE PLACING THE 3.5 MM CORTEX SCREWS WITH A COMPACT DRIVE, THE HEADS OF TWO SCREWS BROKE. THE SCREWS HEADS WERE LEFT IN THE PATIENT BONE. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317687 ↗