NA 204.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982145437), received between Feb 21, 2018 and Mar 6, 2018 — classified as 2 malfunctions.

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

• 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317664 ↗
• MalfunctionFeb 21, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DISTAL TIBIAL OSTEOSYNTHESIS PROCEDURE WAS PERFORMED ON (B)(6) 2018 USING A 3.5MM PROXIMAL TIBIAL PLATE AND A 3.5MM CORTICAL SCREW. THE SCREW WAS PLACED AND A FLEXION MANEUVER WAS PERFORMED TO OBSERVE A LATERAL IMAGE ON THE INTENSIFIER, AT WHICH POINT THE SCREW BROKE. THE SCREW REMAINS IMPLANTED IN THE PATIENT'S BONE. THERE IS NO REPORT OF SURGICAL DELAY OR PATIENT HARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: 3.5MM PROXIMAL TIBIAL PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287149 ↗