NA 292.65Recalls & reported problems
Synthes GmbH · 2.0MM THREADED GUIDE WIRE 230MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982180742), received between Mar 9, 2021 and Jul 12, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break2
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2023Break; Entrapment of Device; Break; Entrapment of Device
THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5118357, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION.
Patient problems: Foreign Body In Patient
MAUDE report 17306861 ↗MalfunctionMar 9, 2021Break
K-WIRE THREADED TIP BROKE AND RETAINED IN PATIENT'S RIGHT FEMUR. BROKEN PIECE SEEN ON FLURO IMAGING. ATTENDING SURGEON DID NOT ATTEMPT TO RECOVER RETAINED PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11444724 ↗
Other Wire, surgical devices
- ATLAS® Cable System 826-213Medtronic Sofamor Danek, Inc. · Wire, surgical14 reports
- NA 292.20Synthes GmbH · Wire, surgical6 reports
- ATLAS® Cable System 826-211Medtronic Sofamor Danek, Inc. · Wire, surgical2 reports
- NA 8555-06-000Depuy International Ltd · Wire, surgical1 report
- NA 292.30Synthes GmbH · Wire, surgical1 report
- NA 292.652Synthes GmbH · Wire, surgical1 report
- CONTROL 1738-30-000Depuy Orthopaedics, Inc. · Wire, surgical1 report
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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