Tools - Screws DVHX-2.0/070C AORecalls & reported problems
Trimed, INC. · Hex Driver 2.0, 70mm AO Cannulated · Class 1
All models of Tools - Screws (7)
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 00842188112713), received between Aug 28, 2017 and Aug 28, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2017Difficult to Remove; Sticking
THE INITIAL COMPLAINT WAS RECEIVED BY (B)(4), TRIMED PRODUCT MANAGER ON (B)(4) 2017. (B)(6), SALES REP, EXPLAINED VIA PHONE THAT SHE WAS JUST IN A CASE WITH DR. (B)(6) WHERE THE DR. WAS DOING A PROXIMAL INTERPHALANGEAL REPAIR (PIP). DURING INSERTION OF THE 3.5 SCREW, LENGTH 28MM (L3528), THE 2.0 DRIVER (DVHX-2.0/070C AO) GOT STUCK IN THE SCREW HEAD. WHEN THE SURGEON TRIED TO SEPARATE THE DRIVER FROM THE SCREW HEAD, SHE PULLED ON THE FINGER AND LOST FIXATION. THE SCREW WOULD NO LONGER PULL THE BONES TOGETHER AND HAD TO BE REMOVED. EVENTUALLY, THE SURGEON WAS ABLE TO REMOVE THE DRIVER AND THE L3528 SCREW. THE SURGEON WAS THEN ABLE TO USE A L3530 SCREW WITH THE SAME DRIVER TO GET BONE PURCHASE AND COMPLETED THE SURGERY SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6825959 ↗
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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