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VARIAX 705132Recalls & reported problems

Stryker GmbH · Screwdriver Blade,AO,T6, self-retaining · Class 1

All models of VARIAX (345)

Data updated Oct 16, 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 07613327398915), received between Jun 26, 2020 and Jun 26, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

  • Fracture2
  • Material Twisted/Bent2

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 26, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

    AS REPORTED: THE T6 SCREWDRIVER BLADES ARE BENDING/ WARPING DURING SURGERY. ONE OF THE T6 SCREWDRIVER BLADE TIPS SNAPPED OFF COMPLETELY.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10200700 ↗
  • MalfunctionJun 26, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

    AS REPORTED: THE T6 SCREWDRIVER BLADES ARE BENDING/ WARPING DURING SURGERY. ONE OF THE T6 SCREWDRIVER BLADE TIPS SNAPPED OFF COMPLETELY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10200689 ↗

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Sources and updates

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