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N/A (REF 310.23)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Drill Bit, QC · 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 00885825011888), received between Jun 15, 2018 and Jun 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Material Fragmentation1

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.

  • MalfunctionJun 15, 2018Break; Material Fragmentation

    SYNTHES 2.5 MM DRILL BIT BROKE INTO TWO PIECES, ONE REMAINING CONTAINED IN THE RIGHT ANKLE SURGICAL SITE. READ FREE OF ANY OTHER METAL FRAGMENTS. OPERATING ROOM TEAM AWARE OF EVENTS.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7605243 ↗

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.