N/A 685.007Recalls & reported problems
Globus Medical, Inc. · 1.6mm Nitinol K-Wire, 500mm, Blunt Tip · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00849044072105), received between Jul 23, 2021 and Sep 22, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture8
- Break6
- Entrapment of Device3
- Human-Device Interface Problem2
- Material Fragmentation2
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Insufficient Information6
- Failure of Implant4
- Foreign Body In Patient3
- Spinal Column Injury3
- Device Embedded In Tissue or Plaque2
- No Clinical Signs, Symptoms or Conditions1
- Vertebral Fracture1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859579 ↗MalfunctionSep 11, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A REVISION SURGERY THE K-WIRE BROKE DURING REMOVAL AND WAS FOUND TO BE REMAIN INSIDE THE PATIENT'S BODY POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 20192748 ↗MalfunctionMar 18, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A CASE THE TIP OF THE K-WIRE BROKE OFF AND WAS RETAINED IN THE PATIENT POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18924825 ↗MalfunctionMar 12, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A CASE THE TIP OF THE K-WIRE BROKE OFF AND WAS RETAINED IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN AUSTRIA.
Patient problems: Spinal Column Injury
MAUDE report 18888336 ↗MalfunctionMar 6, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A CASE THE TIP OF THE K-WIRE BROKE OFF AND WAS RETAINED IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN PANAMA.
Patient problems: Failure of Implant
MAUDE report 18849842 ↗MalfunctionMar 5, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT WHILE PLACING AN S2AI SCREW THROUGH THE K-WIRE, THE TIP BROKE OFF AT THE DISTAL END AND REMAINS IN THE PATIENT'S ILIAC CREST. THIS EVENT OCCURRED IN HONG KONG.
Patient problems: Insufficient Information
MAUDE report 18837393 ↗MalfunctionMar 5, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE REMOVING THE WIRE, THE TIP OF A K-WIRE BROKE OFF AT THE DISTAL END AND REMAINS IN THE PATIENT. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18834231 ↗MalfunctionMar 4, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE K-WIRE BROKE OFF IN THE PATIENT'S VERTEBRAL BODY WHEN ATTEMPTING TO REMOVE THE K-WIRE.
Patient problems: Insufficient Information
MAUDE report 18832753 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE K-WIRE BROKE OFF IN THE PATIENT'S VERTEBRAL BODY WHEN ATTEMPTING TO REMOVE THE K-WIRE.
Patient problems: Failure of Implant
MAUDE report 18832718 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE K-WIRE BROKE OFF WITHIN THE PATIENT AND WAS NOT RETRIEVED.
Patient problems: Failure of Implant
MAUDE report 18831308 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE K-WIRE AFTER THE SCREW HAD BEEN PLACED, THE TIP OF THE K-WIRE BROKE OFF AND WAS LEFT IN THE SCREW.
Patient problems: Failure of Implant
MAUDE report 18830492 ↗MalfunctionMar 1, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE PLACING SCREWS, THE TIP OF A K-WIRE BROKE OFF AT THE DISTAL END AND REMAINS IN THE PATIENT'S VERTEBRAL BODY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Vertebral Fracture
MAUDE report 18822274 ↗MalfunctionFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE PROCESS OF TAPPING RIGHT S1 PEDICLE, THE TIP OF THE GUIDE WIRE (685.007) BROKE OFF AND WAS LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18809992 ↗MalfunctionFeb 23, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT DURING A CASE THE TIP OF THE K-WIRE BROKE OFF AND WAS RETAINED IN THE VERTEBRAL BODY POST OPERATIVELY.
Patient problems: Spinal Column Injury
MAUDE report 18767314 ↗MalfunctionFeb 2, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT DURING SURGERY THE K-WIRE BROKE DURING REMOVAL AND WAS FOUND TO BE REMAIN INSIDE THE PATIENT'S BODY POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 18633037 ↗MalfunctionJan 13, 2023Break; Entrapment of Device
IT WAS REPORTED THAT WHILE PLACING SCREWS, THE TIP OF (2) K-WIRES BROKE OFF AT THE DISTAL ENDS AND REMAIN IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 16161396 ↗MalfunctionDec 29, 2022Break; Entrapment of Device
IT WAS REPORTED THAT WHILE PLACING A SCREW, THE TIP OF THE K-WIRE BROKE OFF AT THE DISTAL END AND REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 16067401 ↗MalfunctionDec 16, 2022Break
IT WAS REPORTED THAT A K-WIRE TIP BROKE AND REMAINS IN PATIENT. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Foreign Body In Patient
MAUDE report 15994831 ↗MalfunctionMar 3, 2022Break
IT WAS REPORTED THAT A K-WIRE TIP BROKE AND REMAINS IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 13660394 ↗MalfunctionJul 23, 2021Break; Entrapment of Device
IT WAS REPORTED BY A REPRESENTATIVE FROM (B)(6) THAT A K-WIRE TIP BROKE AND REMAINS IN PATIENT AT S1.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12221643 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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