NA 03.611.033Recalls & reported problems
Synthes GmbH · 3.0MM SETSCREW EXTRACTOR-LONG · 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 10705034713861), received between Apr 19, 2021 and Apr 19, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
- Material Integrity Problem1
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.
MalfunctionApr 19, 2021Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A SCREW REMOVAL PROCEDURE FOR UNKNOWN REASON. BROKE AN EASY OUT TRYING TO REMOVE AN ORTHO-PEDIATRICS 7MM SCREW. A BROKEN PIECE RETAINED INSIDE SCREW. FRAGMENTS WERE GENERATED AND WERE RETAINED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 11685741 ↗
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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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