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NA 4200355040Recalls & reported problems

Stryker Corporation · 4.0mm Radiolucent Drill Bit · Class 1

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 04546540217172), received between Apr 8, 2021 and Apr 8, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • MalfunctionApr 8, 2021Fracture; Fracture

    IT WAS REPORTED THAT DURING A TFNA PROCEDURE THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT A FRAGMENT REMAINED IN THE PATIENT. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THERE WAS A DELAY OF TWENTY (20) MINS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 11636164 ↗

Other BIT, SURGICAL devices

All BIT, SURGICAL devices →

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