VARIAX 703713Recalls & reported problems
Stryker GmbH · Screwdriver Blade T10 AO Fitting · Class 2
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540687647), received between Aug 15, 2018 and Feb 12, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
- Fracture2
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2020Break; Fracture; Break; Fracture
THE DEVICE BROKE OFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9703334 ↗MalfunctionApr 2, 2019Break; Fracture; Fracture
IT WAS REPORTED THAT WHEN THE SCREW WAS TIGHTENED WITH DRIVER BLADE, TIP OF THE DRIVER BLADE WAS BROKEN. ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT'S BODY. AFTER THAT, SCREW WAS INSERTED WITH OTHER DRIVER AND THE OPERATION WAS FINISHED SUCCESSFULLY. NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8474786 ↗MalfunctionAug 15, 2018Break
TRIED TO PULL OUT THE FIRST SCREW MANUALLY AT THE TIME OF OPERATION OF THE NAVEL CLIPPERS NAIL, THE TIP OF THE DRIVER BROKE. FINISHED THE PROCEDURE WITH A SUBSTITUTE DRIVER. THE BROKEN TIP WAS REMOVED OUT OF PATIENT BODY.
Patient problems: No Code Available
MAUDE report 7784907 ↗
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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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