NA 314.675Recalls & reported problems
Synthes GmbH · 2.0MM CRUCIFORM SCRWDRVR BLADE W/SPRING HOLDING SLV-SHORT-HX · 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 10887587037639), received between May 15, 2019 and May 15, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Most reported problems
Device problems
- Material Twisted/Bent2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) CRUCIFORM SCREWDRIVER BLADE WITH SPRING HOLDING SLEEVE WERE STRIPPED AND NOT WORKING PROPERLY DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.0MM CRUCIFORM SCREWDRIVER BLADE W/SPRING HOLDING SLV-SHORT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8613201 ↗MalfunctionMay 15, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) CRUCIFORM SCREWDRIVER BLADE WITH SPRING HOLDING SLEEVE WERE STRIPPED AND NOT WORKING PROPERLY DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.0MM CRUCIFORM SCREWDRIVER BLADE W/SPRING HOLDING SLV-SHORT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8612886 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
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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