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Hallu®-FIX 129735NDRecalls & reported problems

Newdeal · The snap-off screwdriver tip, with a 6.0mm diameter tri shank attachment, is used to implant or explant the snap-off 2.7 & 3.0mm screws. It has a specific spanner slotted-like tip with three equidistant threads designed to fit the snap off screw head. · Class 1

Data updated Oct 16, 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 10381780052203), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 3, 2023Fracture; Fracture

    IT WAS REPORTED THAT, DURING PLATE AND SCREWS REMOVAL SURGERY, WHILE UTILIZING A SCREWDRIVER TIP THE TOOTH PART BROKE. HOWEVER, THIS DIDN¿T AFFECT THE OUTCOME OF THE SURGERY AND THE SCREWS AND PLATE WERE SUCCESSFULLY REMOVED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16479722 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources and updates

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