NA 314.26Recalls & reported problems
Synthes GmbH · LARGE HEXAGONAL SCREWDRIVER LONG · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982188724), received between Aug 18, 2020 and Mar 28, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (3 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
- Material Twisted/Bent3
- Material Integrity Problem2
- Contamination /Decontamination Problem1
- Corroded1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVERS WERE FOUND STRIPPED AND TOMMY BAR BEING BENT. SD03.127.007 & 008 WON¿T CONNECT PLATE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21720547 ↗MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVERS WERE FOUND STRIPPED AND TOMMY BAR BEING BENT. SD03.127.007 & 008 WON¿T CONNECT PLATE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21720453 ↗MalfunctionApr 13, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WOOD HANDLED INSTRUMENTS ARE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEEL-PACKED AND STERILIZED. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 2 OF 14 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16738294 ↗MalfunctionJul 22, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS SHOWING SIGNS OF OXIDATION AND WEAR. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12211269 ↗MalfunctionAug 18, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) REPORTED THAT THE TWO (92) LARGE HEXAGONAL SCREWDRIVERS WERE FOUND TO HAVE DAMAGED HANDLES. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) LARGE HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10422296 ↗MalfunctionAug 18, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) REPORTED THAT THE TWO (92) LARGE HEXAGONAL SCREWDRIVERS WERE FOUND TO HAVE DAMAGED HANDLES. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) LARGE HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10422290 ↗
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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