VariAx 45-27010Recalls & reported problems
Stryker GmbH · DRILL, WL 50MM, AO-SHAFT · Class 1
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540645791), received between Oct 26, 2018 and Nov 27, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- No Known Impact Or Consequence To Patient1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2019Break; Break
A REPORT WAS RECEIVED FROM (B)(6) HOSPITAL; A SALES REP WAS INFORMED ON 1.11.2019 THAT A VARIAX 2 FOOT DRILL WAS BROKEN DURING FOOT OPERATION. THE DRILL WAS BROKEN SO THAT THE BIT OF THE DRILL STAYED FOR THE PATIENT. IT TOOK 5 MINUTES EXTRA FOR THE OPERATION AND TO GET THE DRILL BIT AWAY FROM THE PATIENT AND FIND A NEW DRILL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9387545 ↗InjuryOct 26, 2018Break
THE TIP OF THE DRILL BREAKS DURING OPERATION OF THE SKULL DISTAL OSTEOSYNTHESIS. THE DRILL PASSED THROUGH THE SKIN ON THE OTHER SIDE.
Patient problems: Perforation
MAUDE report 8010757 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 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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