NA 03.611.142Recalls & reported problems
Synthes GmbH · T20 HEXALOBE DRIVER-MALE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034714424), received between Dec 15, 2016 and Dec 15, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Bent” (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.
Most reported problems
Device problems
- Bent1
- Break1
- Material Distortion1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2016Bent; Break; Material Distortion; Bent; Break; Material Distortion
IT WAS REPORTED ON (B)(6) 2016, THAT THE T20 HEXALOBE DRIVER-MALE SCREWDRIVER IS TWISTED AND DEFORMED. THERE WAS NO SURGERY OR PATIENT INVOLVEMENT. UPON RECEIVING THE DEVICE AT MANUFACTURER, IT WAS NOTED THAT THE DRIVE TIP WAS MISSING A SEGMENT (THE DISTAL-MOST 2.65MM OF THE TIP). ADDITIONALLY THE TIP WAS FOUND TO BE TWISTED IN A MANNER CONSISTENT WITH REMOVAL. THIS REPORT IS FOR ONE (1) T20 HEXALOBE DRIVER-MALE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 6176635 ↗
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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