Skip to content

N/A (REF 310.35)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Drill Bit, QC · Class 1

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 00885825011796), received between Mar 30, 2023 and Mar 30, 2023 — classified as 1 injury.

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

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryMar 30, 2023Break; Break

    IT WAS REPORTED THE END OF THE DRILL BIT BROKE OFF WHILE DRILLING INTO THE HUMERAL PLATE AND THAT THE DOCTOR LEFT THE REMAINING DRILL PIECE IN THE HEAD OF THE HUMERUS. THE COMPLAINANT IS NOT AWARE OF ANY OTHER PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: Foreign Body In Patient

    MAUDE report 16651772 ↗

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.