NA 03.043.013Recalls & reported problems
Synthes GmbH · GUIDE WIRE- W/ STOP / Ø 3.2MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982297273), received between Aug 30, 2023 and Sep 29, 2026 — classified as 4 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. 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
- Break3
- Device-Device Incompatibility2
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931001 ↗MalfunctionJun 16, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE PRODUCT BROKE. WHEN THE OLIVE-SHAPED GUIDEWIRE WAS REMOVED, IT BECAME STUCK IN THE NAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212702 ↗MalfunctionDec 11, 2023Break; Break
DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE BIT IN QUESTION WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A GUIDE WIRE- W/ STOP / Ø 3.2MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18305155 ↗MalfunctionAug 30, 2023Break; Entrapment of Device; Break; Entrapment of Device
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, OF BROKEN INSTRUMENT. INTRAMEDULLARY NAILING OF TIBIA. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED WITHOUT INCIDENT. FRAGMENTS WERE GENERATED. THE DEVICE BROKE INTO TWO PARTS. ONE WAS LEFT INSIDE AS THE RISK OF SURGERY WAS GREATER THAN THE RISK OF THE PART. THERE WERE NO PATIENT ADVERSE EVENT OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) GUIDEWIRE W/STOP Ø3.2 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17649779 ↗
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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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