NA 1806-0180Recalls & reported problems
Stryker GmbH · Tissue Protection Sleeve, Short · 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 04546540196132), received between Apr 13, 2022 and Jan 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT: THE DRILL SLEEVE / FABRIC SLEEVE IS BENT / JAMMED WITH THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21150589 ↗MalfunctionApr 13, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam
AS REPORTED: "DURING REVISION SURGERY, MISTARGET WAS OCCURRED WITH THE TARGET DEVICE AT 1ST AND 4TH SCREWHOLES FROM PROXIMAL. ALSO, THE DRILL SLEEVE BECAME STUCK IN THE GUIDE SLEEVE, AND WHEN IT WAS FORCIBLY PULLED OUT WITH PLIERS, THE THREADS OF THE GUIDE SLEEVE WERE CRUSHED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14107999 ↗
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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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