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NA XFO051201Recalls & reported problems

Stryker GmbH · Cannulated Drill Bit & Countersink · Class 1

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 07613252265481), received between Jun 27, 2019 and Sep 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Defective Device1
  • Fracture1
  • Material Deformation1
  • Material Frayed1
  • Structural Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionSep 20, 2019Material Frayed; Structural Problem; Material Frayed

    THE CUSTOMER REPORTED THAT THE TOP OF THE CANNULATED DRILL BIT HAS FEATHERED.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 9099821 ↗
  • MalfunctionJun 27, 2019Fracture; Material Deformation; Fracture; Defective Device; Material Deformation

    IT HAS BEEN REPORTED BY THE CUSTOMER THAT DURING THE USE OF THE DRILL, THE TIP OPENS AND CAN NOT BE USED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8739914 ↗

Other INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices

All INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.