Medline 375951100RRecalls & reported problems
Medline Industries, Inc. · 375-951-100 FRML BARREL BUR,6-FLT BLU · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10888277381025), received between Oct 31, 2016 and Sep 25, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2019Material Fragmentation
IT WAS REPORTED THAT THE REPROCESSED STRYKER FORMULA¿ BARREL BUR WAS RELEASING METAL SHAVINGS DURING SHOULDER ARTHROSCOPY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9119185 ↗MalfunctionOct 31, 2016Material Fragmentation; Material Fragmentation
MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT A REPROCESSED STRYKER FORMULA BARREL BUR LEFT METAL SHAVINGS IN THE PATIENT DURING A SHOULDER ARTHROSCOPY PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THE INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6068233 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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