NA 04.214.109Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982120847), received between May 8, 2019 and Apr 3, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A TRAUMA PROCEDURE FOR A HAND FRACTURE ON (B)(6) 2023, THE SCREWDRIVER WAS TWISTED AND DIDN¿T FUNCTION PROPERLY. THE SCREW THEN STRIPPED, AND THE SURGEON BROKE THE PLATE IN AN EFFORT TO REMOVE THE SCREW. THERE WAS A SURGICAL DELAY OF 10 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCE TO THE PATIENT. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 9MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663030 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE SURGEON TWISTED THE TOP OFF A 9MM TI CORTEX SCREW (1.5MM SET) AND BROKE A 1.1MM DRILL BIT; BOTH BROKE INSIDE THE PATIENT AND ALL PIECES WERE REMOVED. X-RAYS WERE TAKEN TO AID THE REMOVAL PROCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FORTY-FIVE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.5MM TITANIUM (TI) CORTEX SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939074 ↗
• MalfunctionMay 8, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, WHILE SCREWING IN A 9MM 1.5 CORTEX SCREW FROM SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM THE SCREW HEAD BROKE OFF. THERE WAS A 3-5 MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.5MM TI CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591915 ↗