Medline 375950100RRecalls & reported problems
Medline Industries, Inc. · 375-950-100 FRML RND BUR,6-FLT BLUE/B · Class 2
Data updated Oct 16, 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 10888277382855), received between Nov 15, 2016 and Dec 15, 2016 — 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 16, 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.
MalfunctionDec 15, 2016Material Fragmentation; Material Fragmentation
A STRYKER FORMULA¿ ROUND BUR LEFT METAL SHAVINGS IN THE PATIENT'S KNEE DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6175821 ↗MalfunctionNov 15, 2016Material Fragmentation; Material Fragmentation
MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT A REPROCESSED STRYKER FORMULA" ROUND BUR, MODEL 375-950-100, LEFT METAL SHAVINGS INSIDE THE SURGICAL SITE DURING USE. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6103076 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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