Guide Wire 35094-100-HRecalls & reported problems
I.T.S. GmbH · Guide Wire, Steel, D=0.9mm, L=100mm, TR Round · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09120047301180), received between Feb 3, 2023 and Feb 3, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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.
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2023Fracture; Fracture
IT WAS REPORTED THAT A K-WIRE BROKE INTRAOPERATIVELY DURING A SURGERY OF A HEADLESS COMPRESSION SCREW. ALL PARTS COULD BE REMOVED FROM THE PATIENT. NO CONSEQUENCES ARE EXPECTED AND NO SIGNIFICANT DELAY IN SURGERY OCCURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16290097 ↗MalfunctionFeb 3, 2023Fracture; Fracture
IT WAS REPORTED THAT A K-WIRE BROKE INTRAOPERATIVELY DURING A SURGERY OF A HEADLESS COMPRESSION SCREW. ALL PARTS COULD BE REMOVED FROM THE PATIENT. NO CONSEQUENCES ARE EXPECTED AND NO SIGNIFICANT DELAY IN SURGERY OCCURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16290096 ↗
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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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