NA 1320-3642SRecalls & reported problems
Stryker GmbH · Drill, AO · Class 1
Data updated Oct 18, 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 07613154490875), received between Nov 6, 2022 and May 22, 2023 — 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 18, 2026.
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A DRILL BIT BROKE DURING SURGERY. IT WOULD HAVE BEEN MORE HAZARDOUS TO ATTEMPT TO RETRIEVE THE REMAINING DRILL BIT FROM THE PATIENT'S BONE SO IT WAS DECIDED TO BE LEFT IN.
Patient problems: Foreign Body In Patient
MAUDE report 16972651 ↗MalfunctionNov 6, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE DEVICE BROKE.
Patient problems: Insufficient Information
MAUDE report 15741348 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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