SKYLINERecalls & reported problems across all models
Depuy Spine, LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 8 models of SKYLINE by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2018 and Mar 18, 2026 — classified as 1 injury, 34 malfunctions.
The most frequently reported specific device problem is “Break” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SKYLINE problems
Device problems
- Break18
- Device-Device Incompatibility10
- Material Twisted/Bent10
- Contamination /Decontamination Problem2
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient6
- No Patient Involvement2
- Foreign Body In Patient1
- Insufficient Information1
SKYLINE models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SKYLINE 286850000DRIVER, PROSTHESIS12 reports
- SKYLINE 286830700DRIVER, PROSTHESIS10 reports
- SKYLINE 286830400DRIVER, PROSTHESIS5 reports
- 4 reports
- SKYLINE 286810100Guide, surgical, instrument1 report
- SKYLINE 286810300Guide, surgical, instrument1 report
- SKYLINE 286820014BIT, DRILL1 report
- SKYLINE 286820016BIT, DRILL1 report
Recent SKYLINE adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
STILL CONTAMINATED INSTRUMENTS AFTER REPROCESSING. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789218 ↗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 ↗MalfunctionJun 25, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE SCREWDRIVERS SEEMED TO STRIP DURING SCREW PLACEMENT. PATIENT STATUS WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331639 ↗MalfunctionJun 25, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE SCREWDRIVERS SEEMED TO STRIP DURING SCREW PLACEMENT. PATIENT STATUS WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331638 ↗MalfunctionJun 2, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THE SKYLINE PLATE DTS GUIDE IS WORN OUT AND NO-LONGER HOLDS THE PLATE SECURELY WHILE DRILLING, TAPPING AND SCREWING. THIS WAS DISCOVERED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS, A FIFTEEN (15) MINUTE SURGICAL DELAY AND NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122301 ↗MalfunctionJan 8, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. WHEN THE OPERATION WAS CARRIED OUT, IT WAS DISCOVERED THAT THE INSERTER WAS BROKEN INTO TWO PARTS. THE INNER SHAFT WAS NO LONGER IN CONTACT WITH THE HANDLE. THE OPERATION COULD BE CARRIED OUT AS USUAL. THE OPERATION TIME WAS NOT EXTENDED BY THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21106027 ↗MalfunctionJan 8, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. WHEN THE OPERATION WAS CARRIED OUT, IT WAS DISCOVERED THAT THE INSERTER WAS BROKEN INTO TWO PARTS. THE INNER SHAFT WAS NO LONGER IN CONTACT WITH THE HANDLE. THE OPERATION COULD BE CARRIED OUT AS USUAL. THE OPERATION TIME WAS NOT EXTENDED BY THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21106026 ↗MalfunctionApr 26, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE FIXATION PIN INSERTER IS NOT RETAINING THE PINS. UNKNOWN IF SURGERY WAS DELAYED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) SKY TFP INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19197266 ↗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 ↗MalfunctionFeb 13, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
MalfunctionFeb 13, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
MalfunctionOct 16, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE INNER SHAFT OF THE SELF CENTERING SKYLINE AWL BROKE WHILE BEING USED BY THE SURGEON. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) SKY SELF CENTERING AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940814 ↗
Other Depuy Spine, LLC products
All Depuy Spine, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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