NA 03.611.059Recalls & reported problems
Synthes GmbH · EXTENDER-6MM HXC · 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 10705034713984), received between Apr 17, 2019 and Mar 26, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (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
- Compatibility Problem2
- Device-Device Incompatibility1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Compatibility Problem
IT WAS REPORTED THE INSTRUMENT ARE STUCK TOGETHER. THE DEVICES WERE PART OF OUR SPINE REMOVAL KIT LOANER. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696737 ↗MalfunctionNov 26, 2024Compatibility Problem; Compatibility Problem
IT WAS REPORTED ON NOVEMBER 14, 2024, THE INSTRUMENT ROOM TECHNICIAN WAS INSPECTING AND ASSEMBLING INSTRUMENTS FOR STERILIZATION AND HE WAS UNABLE TO DISENGAGE (EXTENDER 6 MM HEX) FROM (RATCHETING T-HANDLE). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20777128 ↗MalfunctionSep 12, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE ADAPTERS ARE BENT/WARPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR AN EXTENDER-6MM HXC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20205003 ↗MalfunctionApr 17, 2019Device-Device Incompatibility; Device-Device Incompatibility
CONCOMITANT DEVICE REPORTED: UNKNOWN ROD(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN).
Patient problems: No Patient Involvement
MAUDE report 8525091 ↗
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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