VARIAX 703896Recalls & reported problems
Stryker GmbH · Drill Bit, AO, Scaled · Class 1
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327070064), received between Jul 15, 2020 and Mar 19, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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
- Fracture7
- Break1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2026Fracture
IT WAS REPORTED VIA MEDWATCH #MW5182803: "DRILL BIT USED IN A JOINT OF THE FOOT. AFTER USE AND EXAMINATION, IT WAS NOTED THAT THE TIP OF THE DRILL WAS BROKEN. DRILL BIT WAS LEFT IN BONE AS ATTEMPTING TO REMOVE IT COULD CAUSE MORE DAMAGE". NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 24640819 ↗MalfunctionSep 26, 2025Break; Fracture; Break; Fracture
AS REPORTED: "DESCRIPTION OF EVENTS: THE FIBULA ANCILLARY DRILL BIT BROKE IN THE PATIENT'S WRIST DURING DRILLING WHILE INSERTING A VARIAX WRIST PLATE. THE ENTIRE TIP WAS RECOVERED, AND AN X-RAY WITH MAGNIFICATION WAS PERFORMED TO ENSURE THAT NO PIECES REMAINED IN THE PATIENT'S BONE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23154776 ↗MalfunctionAug 21, 2024Material Deformation; Material Deformation
THE COMPANY REP REPORTED DEFECTIVE DRILL BIT TIPS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20023170 ↗MalfunctionJun 25, 2021Fracture; Fracture
IT WAS REPORTED THE DRILL BIT BROKE DURING USE. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PART. THERE WERE NO REPORTED ADVERSE CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY IN TREATMENT.
Patient problems: Foreign Body In Patient
MAUDE report 12068913 ↗MalfunctionMay 10, 2021Fracture; Fracture
IT WAS REPORTED THAT 3 DRILL BITS BROKE OFF DURING A DISTAL RADIUS SURGERY. THE SURGERY WAS COMPLETED WITH A REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803707 ↗MalfunctionMay 10, 2021Fracture; Fracture
IT WAS REPORTED THAT 3 DRILL BITS BROKE OFF DURING A DISTAL RADIUS SURGERY. THE SURGERY WAS COMPLETED WITH A REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803705 ↗MalfunctionMay 7, 2021Fracture; Fracture
IT WAS REPORTED THAT 3 DRILL BITS BROKE OFF DURING A DISTAL RADIUS SURGERY. THE SURGERY WAS COMPLETED WITH A REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11794429 ↗MalfunctionJul 15, 2020Fracture; Fracture
IT WAS REPORTED: THE DRILL BIT BROKE OFF. A NEW DRILL BIT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. SURGICAL DELAY OF 15MIN. NOT LONGER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10278878 ↗
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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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