NA 619905SRecalls & reported problems
Stryker GmbH · Washer · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540430335), received between Aug 18, 2025 and Aug 18, 2025 — classified as 1 injury.
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. 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
- Break1
- Fracture1
- Material Deformation1
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.
InjuryAug 18, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation
IT WAS REPORTED THAT: "A SCREW FROM THE ASNIS III RANGE BECAME DEFORMED AND EVENTUALLY BROKE AT THE HEAD DURING ABLATION ON A 14-YEAR-OLD PATIENT, MAKING ABLATION IMPOSSIBLE." MEASURES/ACTIONS TAKEN TO COMPLETE THE PROCEDURE: BREAK THE SCREW FLUSH WITH THE CORTEX AND LEAVE THE REMAINING PART IN PLACE. 3/10/2025 - ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: "DURING THE REMOVAL PROCEDURE, I EASILY FOUND THE END OF THE SCREW, WITH THE HELP OF A GUIDE PIN, BUT I TRIED TO REMOVE IT FOR 45 MIN (TOURNIQUET TIME 69 MIN INSTEAD OF THE PLANNED 20-30 MIN), WITH A SHARP BROKEN END OF THE SCREW WHEN IT BROKE OFF, POTENTIALLY IRRITATING THE OVERLYING TENDONS." 7/23/2025: UPON DEEP INSPECTION OF THE RETURNED SCREW, IT HAS BEEN NOTICED THAT A WASHER WAS ALSO RETURNED. THE WASHER IS ALSO BROKEN.
Patient problems: Foreign Body In Patient
MAUDE report 22835358 ↗
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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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