VARIAX 703691Recalls & reported problems
Stryker GmbH · Drill Bit, AO Dia2.6mm x 135mm, Scaled · 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 07613327069860), received between Nov 12, 2021 and Nov 12, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Mechanical Jam1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam
THE CUSTOMER REPORTED THAT DRILL HAS BEEN 'WELDED' INTO THE DRILL GUIDE RESULTING IN THE DRILL TO BREAK DURING DRILLING. SURGEON SAID THERE WAS BURNING BONE AS A RESULT AND SO USED SALINE TO COOL IT DOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12802403 ↗
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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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