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NA 60-13506Recalls & reported problems

Stryker Leibinger GmbH & Co. KG · Drill for 6mm Screws, Stryker Shaft · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540366498), received between Apr 1, 2021 and Apr 1, 2021 — classified as 1 injury.

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

  • Foreign Body In Patient1
  • 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.

  • InjuryApr 1, 2021Fracture; Fracture

    IT WAS REPORTED THAT THE DRILL BIT BROKE DURING DRILLING AND A PIECE BROKE OFF AND REMAINS IN PATIENTS SINUS.

    Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11605657 ↗

Other DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices

All DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices →

Sources and updates

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