SKYLINE 286830400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034215419), received between Mar 18, 2024 and Mar 18, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT INTRA-OPERATIVELY BOTH SKYLINE SCREWDRIVER ENDS BROKE AWAY FROM THE SHAFT RENDERING THEM UNUSABLE, THIS CAUSED A MINUTES DELAY IN THE SURGERY AS WE OPENED ANOTHER TRAY BUT HAD NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631844 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT INTRA-OPERATIVELY BOTH SKYLINE SCREWDRIVER ENDS BROKE AWAY FROM THE SHAFT RENDERING THEM UNUSABLE, THIS CAUSED A MINUTE DELAY IN THE SURGERY AS WE OPENED ANOTHER TRAY BUT HAD NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626072 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT INTRA-OPERATIVELY BOTH SKYLINE SCREWDRIVER ENDS BROKE AWAY FROM THE SHAFT RENDERING THEM UNUSABLE. THIS CAUSED A MINUTE DELAY IN THE SURGERY AS WE OPENED ANOTHER TRAY. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598102 ↗
• MalfunctionNov 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS FOUND THAT INSTRUMENTS HAVE WORN DOWN AND STRIPPED DUE TO USAGE OVER TIME. THE DRILLS DID NOT CUT THROUGH BONE ADEQUATELY AND THE DRIVERS DID NOT HOLD A SCREW. THE COUPLING ON THE HANDLE WAS JARRED. ITEMS HAVE BEEN REMOVED FROM CIRCULATION. MULTIPLE SETS NEEDED TO BE OPENED TO FIND ALTERNATION INSTRUMENTS. THERE WAS A 10 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572138 ↗
• MalfunctionMar 18, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON FEBRUARY 29, 2024, THAT THE SKYLINE WAS BROUGHT IN ON A LONG TERM LOAN. SURGEON WAS TRIALLING SKYLINE ANTERIOR CERVICAL PLATING SYSTEM IN RVI. THE X15 EXPANSION TIP SCREWDRIVER WOULD NOT RETAIN THE SCREWS AND THEREFORE COULD NOT BE USED. THE OTHER TWO NORMAL SCREWDRIVERS ALSO SEEMED TO BE STRIPPED AND WOULD NOT RETAIN THE SCREWS DESPITE SEVERAL EFFORTS. TRIED TO LOAD 4X DIFFERENT SCREWS AND HAD THE SAME ISSUE WITH EACH SCREW. SURGEON USED A PLATING SYSTEM FROM ANOTHER COMPANY WHICH WAS READILY AVAILABLE IN THEATRE. THERE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR ONE (1)SKYLINE STANDARD DRIVER THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923486 ↗