NA 1806-0292Recalls & reported problems
Stryker GmbH · Screwdriver Shaft 3,5 x 85 mm · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540353283), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2021Break; Break
AS REPORTED: "DURING REMOVAL SURGERY, THE TIP OF THE SCREWDRIVER WAS BROKEN OFF WHEN REMOVING THE END CAP. THE TIP OF THE SCREWDRIVER BROKE OFF JUST SHORT OF THE SURFACE OF THE END CAP, SO IT COULD NOT BE REMOVED. ONLY THE LATERAL LOCKING SCREW WAS REMOVED, AND THE NAIL AND END CAP WERE LEFT IN THE PATIENT BODY."
Patient problems: Foreign Body In Patient
MAUDE report 13003416 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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