NA 400.809.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982203687), received between Mar 1, 2023 and Mar 20, 2023 — 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. How this data works · Data updated Oct 13, 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 20, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE USING THE SYNTHESE MOD HAND SET, THE SURGEON NOTICED THAT A 1.5MM CORTEX 9MM SCREW HEAD COMPLETELY BROKE OFF AFTER PLACEMENT. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.5MM TI CORTEX SCREW SELF-TAPPING 9MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574032 ↗
• MalfunctionMar 1, 2023Break

  USING THE SYNTHES MOD HAND SET, DURING PLACEMENT THE SURGEON NOTED THAT A 1.5 MM CORTEX 9 MM SCREW HEAD COMPLETELY BROKE OFF AFTER PLACEMENT. NO HARM AND SCREW SECURED WITH OPERATING ROOM (OR) LEADERSHIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459685 ↗