OASYS IS3107OASRecalls & reported problems
Stryker Corporation · SPECIALTY SCREWDRIVER W/LOCK · Class 1
All models of OASYS (60)
Data updated Oct 18, 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 07613327142181), received between Feb 16, 2016 and Mar 29, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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 18, 2026.
Most reported problems
Device problems
- Crack2
- Fracture2
- Break1
- Detachment of Device or Device Component1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2016Fracture; Material Integrity Problem; Break; Crack; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; SCREWDRIVER TIP CRACKED AND BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5531655 ↗MalfunctionFeb 16, 2016Fracture; Crack; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE DEVICE CRACKED AND ALMOST SHEARED OFF OF THE SCREWDRIVER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5439415 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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