NA 03.168.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982274465), received between May 26, 2022 and Mar 11, 2024 — classified as 3 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 16, 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.

• MalfunctionMar 11, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THAT WHEN REMOVING THE DISTAL LOCKING SCREW (5.0 MM) OF THE FNS SYSTEM, THE TIP OF THE SCREWDRIVER BROKE OFF IN THE SCREW AND GOT STUCK. WE WERE THEN UNABLE TO REMOVE THE SCREW AND HAD TO USE THE OPERACE. THERE WAS NO SURGICAL DELAY FOR ABOUT 15 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT HEX 3.5 L241THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18876181 ↗
• MalfunctionJan 25, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) . THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580563 ↗
• MalfunctionMay 26, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE DEVICE WAS BENDING WHEN REMOVING THE SCREW. THE LOCK SCREW WAS DISCOVERED TO BE STRIPPED. THIS REPORT INVOLVES ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT 241MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518115 ↗