NA 392.00Recalls & reported problems
Synthes GmbH · BENDING IRON FOR 1.25MM, 1.6MM & 2.0MM KIRSCHNER WIRES · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982198594), received between Mar 25, 2021 and Mar 25, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2021Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE KIRSHNER COULD NOT BE REMOVED. THIS REPORT INVOLVES ONE (1) BEND-IRON F/K-WIRES F/WIRES Ø1.25-2.5. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11567927 ↗
Other INSTRUMENT, BENDING OR CONTOURING devices
- TRIGEN 71674576Smith & Nephew, Inc. · INSTRUMENT, BENDING OR CONTOURING18 reports
- NA 329.30Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING7 reports
- MatrixMANDIBLE 03.503.079Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING4 reports
- NA 388.112Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING3 reports
- NA 388.113Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING2 reports
- Coblation E2020-01Smith & Nephew, Inc. · INSTRUMENT, BENDING OR CONTOURING1 report
- MatrixMANDIBLE 03.503.041Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING1 report
- EVOS 71175064Smith & Nephew, Inc. · INSTRUMENT, BENDING OR CONTOURING1 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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