NA 700358Recalls & 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 04546540110251), received between Dec 19, 2018 and Apr 25, 2022 — classified as 2 malfunctions.
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
- Fracture1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY. DEVICE DISPOSED OF BY THE CUSTOMER. UPDATE - "THIS RELATES TO A DRILL BIT WHICH BROKE DURING USE. THE DRILL BIT WHICH SNAPPED OFF WAS LEFT IN THE PATIENT. MY UNDERSTANDING IS THAT IT WAS IN THE POSITION OF THE 4TH SCREW (OF 4) ON A PLATE AND THEREFORE WOULD HAVE BEEN MORE CHALLENGING/IMPACTFUL TO THE PATIENT IF THE SURGEON TRIED TO REMOVE IT. AT PRESENT, THE PATIENT WILL HAVE BEEN MADE AWARE OF THE EVENT, AND WILL PRESUMABLY REQUIRE MONITORING FOR ANY DELAYED COMPLICATIONS."
Patient problems: Foreign Body In Patient
MAUDE report 14192827 ↗MalfunctionDec 19, 2018Break
THE HOSPITAL REPORTED THE FOLLOWING EVENT : " 44-YEAR-OLD PATIENT, HOSPITALIZED FOR OSTEOSYNTHESIS OF THE RIGHT HUMERUS.THE WICK USED FOR DISTAL LOCKING OF THE HUMERAL NAIL BROKE IN THE PATIENT'S BODY AND HIS EXTREMITY COULD NOT TO BE REMOVED. TWO OTHER STRANDS (DIFFERENT SOCIETY) WERE ALSO BROKEN DURING THE SAME PROCEDURE (OUR AA REFERENCES 2018/1088). THE DEVICE HAS BEEN RETAINED FOR EXPERTISE." CLINICAL CONSEQUENCES NOTED: THE ENDS OF THE BROKEN BITS REMAINED IN THE PATIENT'S BODY ARE NOT KNOWN. EXTENSION OF THE INTERVENTION TIME.
Patient problems: Foreign Body In Patient
MAUDE report 8182754 ↗
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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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