G/K 0152-0218Recalls & reported problems
Stryker GmbH · K-Wire · Class 1
Data updated Oct 16, 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 04546540143471), received between Aug 27, 2015 and Aug 27, 2015 — classified as 1 malfunction.
The most frequently reported specific device problem is “Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Bent1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2015Bent
THE CUSTOMER, NURSE INFORMED TO PRODUCT SPECIALIST OF TRAUMA THAT GAMMA3 K-WIRES ((B)(4)) WERE SENT TO THE NORTH KARELIA CENTRAL HOSPITAL. THE CUSTOMER WAS PLANNING TO PUT THE K-WIRES INTO THE GAMMA3 INSTRUMENTATION SET BUT NOTICED THAT THE K-WIRES WERE NOT STRAIGHT. CUSTOMER IS CONCERN THAT IS IT SAFE TO USE THIS KIND OF SLIGHTLY BEND K-WIRES IN A OPERATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5035649 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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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