VARIAX 703896SRecalls & reported problems
Stryker GmbH · Drill Bit, AO Dia2.0mm x 135mm, Scaled · Class 1
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 07613327071870), received between Dec 8, 2025 and Jan 5, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Fracture
AS REPORTED: "DURING SURGERY TO PLACE A DISTAL RADIUS PLATE, THE DRILL BIT PENETRATED TOWARD THE DORSAL SIDE DURING DRILLING, BECAME ENTANGLED IN THE STOCKINETTE, AND THE TIP BROKE OFF. IT BROKE OFF OUTSIDE THE PATIENT BODY, NO FRAGMENTS REMAIN INSIDE THE BODY."
Patient problems: Perforation
MAUDE report 23969565 ↗MalfunctionDec 30, 2025Fracture; Fracture
AS REPORTED: "THE DRILL BROKE OFF DURING THE SURGERY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23922421 ↗MalfunctionDec 8, 2025Fracture; Fracture
AS REPORTED: "A DRILL BIT FRACTURED DURING ORIF FOR A DISTAL RADIUS FRACTURE. A FRAGMENT TEMPORARILY BECOME LODGED IN THE PATIENT'S BONE BUT WAS PROMPTLY REMOVED. THE OPERATION WAS COMPLETED WITHOUT FURTHER INCIDENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742095 ↗
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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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