NA 314.68Recalls & reported problems
Synthes GmbH · 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, LONG · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587037660), received between Dec 16, 2020 and Apr 6, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVERS ARE WORN OUT. THEY DO NOT ENGAGE SCREW HEADS PROPERLY ANYMORE. THE SURGERY WAS DELAYED 2 MINUTES DUE TO THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794233 ↗MalfunctionApr 6, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVERS ARE WORN OUT. THEY DO NOT ENGAGE SCREW HEADS PROPERLY ANYMORE. THE SURGERY WAS DELAYED 2 MINUTES DUE TO THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794228 ↗MalfunctionDec 16, 2020Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN AUDIT OF THE HAND TRAYS THE FOLLOWING ISSUES WERE DISCOVERED: THE STAR SCREWDRIVERS ARE WORN AND DO NOT SELF-CAPTURE SCREWS. ONE OF THE FLANGES ON THE CROSS HAVE BROKEN OFF OF THE CRUCIFORM DRIVER. THIS REPORT IS FOR 1 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, LONG. THIS IS REPORT 3 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11019335 ↗MalfunctionDec 16, 2020Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN AUDIT OF THE HAND TRAYS THE FOLLOWING ISSUES WERE DISCOVERED: THE STAR SCREWDRIVERS ARE WORN AND DO NOT SELF-CAPTURE SCREWS. ONE OF THE FLANGES ON THE CROSS HAVE BROKEN OFF OF THE CRUCIFORM DRIVER. THIS REPORT IS FOR 1 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, LONG. THIS IS REPORT 1 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11019247 ↗
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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