Vilex Tool ZT702-06-09Recalls & reported problems
Vilex In Tennessee, Inc. · Driver, QC T6 - T20 Screws · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841731116253), received between Mar 28, 2018 and Mar 4, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Break
DURING AN MIS HAMMERTOE PROCEDURE, THE JOINT WAS PREPPED AND PRE-DRILLING PERFORMED PRIOR TO SCREW INSERTION. WHILE ADVANCING THE SCREW, A SMALL SNAP WAS HEARD CAUSING THE SCREWDRIVER TO LOSE ENGAGEMENT. DRIVER TIP WAS INSPECTED AND NOTICEABLY BROKEN. A SECOND DRIVER WAS USED AND RESULTED IN THE SAME BREAKAGE. LARGER INCISION WAS MADE IN ORDER TO REMOVE THE DRIVER FRAGMENTS, TOTAL DELAY IN SURGERY EST. 45 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506207 ↗MalfunctionMar 28, 2018Material Twisted/Bent
DOCTOR WAS USING TITANEX DRIVER (ZT702-06-09) TO INSERT A 2.0MM SCREW. AS HE BEGAN TO DRIVE THE SCREW, THE DRIVER TIP TWISTED. DOCTOR CHANGED TO THE SECOND DRIVER. HE BEGAN TO DRIVE THE SCREW AND AFTER MAKING ONE TURN, DOCTOR NOTICED SLIGHT TWIST IN THE TIP OF THE DRIVER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7379816 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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