NA 1210-6450Recalls & reported problems
Stryker GmbH · K-Wire · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540175359), received between Jul 21, 2021 and Oct 6, 2025 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2025Fracture; Fracture
AS REPORTED: "WHEN ROTATING THE NAIL TO ADJUST ITS POSITION DURING INSERTION OF THE GUIDE PIN FOR THE LAG SCREW, THE GUIDE WAS ROTATED WITHOUT BEING FULLY REMOVED, AND THEN ROTATED AGAIN WITH THE HANDPIECE, CAUSING THE GUIDE PIN TO SHEAR OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23222589 ↗MalfunctionApr 23, 2025Break; Fracture; Break; Fracture
AS REPORTED: "SCHEDULED GAMMA NAIL REMOVAL SURGERY. A GUIDE PIN WAS INSERTED TO REMOVE THE LAG SCREW, BUT THE LAG SCREW DID NOT PULL OUT PROPERLY AND THE GUIDE PIN ALSO GOT STUCK. WHEN SURGEON TRIED TO PULL OUT THE GUIDE PIN WITH PLIERS, TIP OF IT BROKE OFF. SURGEON TRIED AGAIN TO PULL OUT THE LAG SCREW WITH A SCREWDRIVER AND WAS ABLE TO PULL IT OUT WITHOUT ANY PROBLEM. THERE WERE NO RESIDUALS IN THE PATIENT'S BODY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21894465 ↗MalfunctionJan 14, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT CUTTER GOT STUCK ON A THIRD PARTY ATTACHMENT. THE THIRD PARTY TECHNICIAN STATED THAT THE CUTTER MIGHT HAVE CONTRIBUTED TO THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13257205 ↗MalfunctionJul 21, 2021Break; Break
IT WAS REPORTED THAT DURING A GAMMA NAIL PROCEDURE, A K-WIRE BROKE OF IN THE PATIENT WHILE PERFORMING FEMORAL FIXATION. SURGEON DECIDED TO LEAVE THE BROKEN PORTION IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 12206878 ↗
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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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