AXSOS 705022Recalls & reported problems
Stryker GmbH · Drill Guide, non-locking · Class 1
All models of AXSOS (184)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327083491), received between Jan 29, 2019 and Feb 2, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Mechanical Jam
AS REPORTED: "THE DRILL GOT STUCK IN THE SLEEVE AND BROKE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235211 ↗MalfunctionJan 29, 2019Break; Mechanical Jam
PRIMARY PROCEDURE, LEFT PROXIMAL HUMERUS. IT WAS REPORTED THAT A DRILL BIT BOUND UP IN THE 2.5 DRILL GUIDE AND GOT STUCK. WHEN TRYING TO REMOVE THE BIT, APPROXIMATELY 60MM BROKE OFF IN THE GUIDE. PROCEDURE WAS COMPLETED FREE-HANDED, WITH A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES REPORTED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8287415 ↗
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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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