VARIAX 62-23333Recalls & reported problems
Stryker GmbH · Screwdriver Blade 2.3, Cross-Pin, Dental · Class 1
All models of VARIAX (345)
Data updated Oct 18, 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 04546540541017), received between May 26, 2021 and May 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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 18, 2026.
Most reported problems
Device problems
- Component Missing1
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.
MalfunctionMay 26, 2021Component Missing; Component Missing
IT HAS BEEN REPORTED THAT WHEN OPENING THE VARIAX HAND KIT NUMBER PLATE TVARXM28 / IVARXM28 IN THE OPERATING ROOM, WITH THE PATIENT ANESTHETIZED, THEY NOTICED THAT THE TWO SCREWDRIVER BLADES (REF: 62-17333 AND 62-23333) WERE MISSING FROM THE KIT. FACED WITH THE IMPOSSIBILITY OF PLACING THE PLATE AND SCREWS, THE OPERATING SURGEON WAS FORCED TO SYNTHESIZE THE FRACTURE USING KIRSCHNER WIRES AND SUTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11889274 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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