VariAx 58-12010Recalls & reported problems
Stryker GmbH · BONE SCREWS,CROSS-PIN,SELF-T · Class 2 · Implant
All models of VARIAX (345)
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 37613154583233), received between Nov 25, 2019 and Nov 25, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2019Break; Break
PRIMARY HAND PROCEDURE. IT WAS REPORTED THAT AFTER ACHIEVING BI-CORTICAL FIXATION OF THE PATIENT'S FINGER, THE HEAD OF THE SCREW BROKE OFF AS THE SURGEON ATTEMPTED TO GIVE IT AN ADDITIONAL TURN. THE SCREW HEAD WAS REMOVED AND DISPOSED IN THE SHARPS CONTAINER, THE IMPLANTED THREADED PORTION WAS LEFT IN THE BONE. A SECOND SCREW WAS IMPLANTED (SURGEON DID NOT REPORT THIS WAS A RESULT OF THE FIRST SCREW BREAKING) AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. SURGEON REPORTED THAT HE IS SATISFIED WITH THE COMPLETION OF THE PROCEDURE. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9372372 ↗
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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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