MEDLINE 338100RHRecalls & reported problems
Medline Industries, Inc. · 338.100 @DRL BIT FOR DHS/DCS SYS 8MM X 2 · 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 10888277355200), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Cut” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Cut1
Patient problems
- 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.
MalfunctionOct 15, 2025Failure to Cut; Failure to Cut
IT AS REPORTED THE DRILL BIT HAS NO EDGE. IT WAS NOTED IT TOOK 15 MINUTES TRYING TO GET THE BIT THROUGH THE BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23304653 ↗
Other BIT, SURGICAL devices
- Tornier Perform MWJ127Tornier, Inc. · BIT, SURGICAL114 reports
- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.