NA 700356Recalls & reported problems
Stryker GmbH · Drill Bit AO Fitting · Class 1
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 04546540413796), received between Mar 26, 2019 and Dec 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionDec 22, 2025Fracture; Fracture
AS REPORTED: "DURING DRILLING FOR SCREW INSERTION INTO THE PELVIS, THE TIP APPROXIMATELY 17MM LONG BROKE OFF AND REMAINED INSIDE THE BODY. THE OPERATING SURGEON DEEMED IT UNPROBLEMATIC AND CONCLUDED THE PROCEDURE WITH THE FRAGMENT LEFT IN PLACE."
Patient problems: Foreign Body In Patient
MAUDE report 23871900 ↗MalfunctionMar 26, 2019Fracture; Fracture
CUSTOMER REPORTED THAT ABOUT 2CM OF THE DRILL BIT HAS BROKEN OFF AND IT IS LEFT IN THE PATIENT. UNINTENDED METAL LEFT IN PATIENT. THE CONSULTANT ORTHOPAEDIC SURGEON MADE THE DECISION BASED ON LOWEST RISK. DURING THE FOLLOW UP APPOINTMENT, THE PATIENT HAS PROGRESSED WELL AND IS NOT CONCERNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8453744 ↗
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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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