Formula 0385950008Recalls & reported problems
Stryker Corporation · XL, Hip 8-Flute Round Bur. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, 0375-704-500, 0375-708-500. Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight · Class 1
All models of Formula (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07613327055177), received between Aug 19, 2025 and Aug 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionAug 19, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP BROKE OFF. THE BROKEN TIP WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22844390 ↗
Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices
- NA 5820066012Stryker Corporation · Bur, Surgical, General & Plastic Surgery1 recall4 reports
- NA 310.25SSynthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- Arthrex® AR-8400OBEArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY48 reports
- NA 310.21Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY29 reports
- NA 351.27Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Arthrex® AR-8500OBEArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY27 reports
- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
- Arthrex® AR-8150PX-45Arthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY15 reports
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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