NA 313.94.96Recalls & reported problems
Synthes GmbH · 2.4MM CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982188267), received between Jul 8, 2019 and Jun 7, 2023 — classified as 3 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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED, THAT THERE WAS STRIPPED SCREWDRIVER AND BROKEN TISSUE GUIDES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.4 CRUC SCREWDRIVER HOLDING SLEEVE. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17083372 ↗MalfunctionDec 17, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE ITEMS WERE INVOLVED. ONE 1.5/1.1 DRILL GUIDE BROKE, ONE 2.7/2.0 DRILL GUIDE WAS BROKEN WITH A DRILL BIT COLD WELDED INTO IT, AND A CRUCIFORM SCREWDRIVER HEAD WAS STRIPPED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE STATUS WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR 1 2.4MM CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11029155 ↗MalfunctionJul 8, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE WAS FOUND IN STERILE PROCESSING MISSING THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8768246 ↗
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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