NA 324.050Recalls & reported problems
Synthes GmbH · 3.5MM HEXAGONAL SCREWDRIVER SHAFT/SELF-RETAINING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982191052), received between Sep 6, 2021 and Jun 14, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Appropriate Device Problem Term/Code Not Available1
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SCREW DRIVER DID NOT WORK . THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO REPORTED SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT-3.5-HEX L180. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14684379 ↗InjuryFeb 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
INSTRUMENT SCREWDRIVER WAS MISSING IN THE LOANER SET. THEREFORE NO MINIMAL INVASIVE TECHNIQUE COULD HAVE BEEN USED. THE SURGERY TOOK LONGER AND THE INCISION HAD TO BE MADE BIGGER. SURGERY COULD BE FINALIZED. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT-3.5-HEX L180. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Tissue Injury
MAUDE report 13605870 ↗MalfunctionSep 6, 2021Material Twisted/Bent
IT WAS REPORTED THAT, THE TIP OF POWER SHAFT SCREWDRIVER WAS BENT AND NO LONGER USABLE. THIS REPORT IS FOR ONE (1) 3.5 HEX SCRDRIVER SFT/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 12428626 ↗
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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