NA 1346001000Recalls & reported problems
Stryker Corporation · K-Wire, Trocar Pts. 4.0'' x .035'' · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540029478), received between May 1, 2024 and May 1, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER HAND SURGERY, THE PATIENT REPORTED A POTENTIAL ALLERGIC REACTION TO THE IMPLANTED K-WIRE IN THEIR THUMB. ANTIBIOTICS WERE ADMINISTERED FOR POTENTIAL INFECTION. IT WAS ALSO REPORTED THAT THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19225040 ↗
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- SMART TOE ST0A-16PStryker GmbH · PIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- SMART TOE ST0-22PStryker GmbH · PIN, FIXATION, SMOOTH1 recall0 reports
- SMART TOE ST0XS-11Stryker GmbH · PIN, FIXATION, SMOOTH1 recall0 reports
- HammerTube™ System P40-002-0275-SParagon 28, Inc. · PIN, FIXATION, SMOOTH1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
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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