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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

All SCREWDRIVER devices →

Sources and updates

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