Formula 0375534000Recalls & reported problems
Stryker Corporation · [Aggressive Plus Cutter, Arthroscopic Shaver Blade, Do Not Resterilize, 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327061741), received between Sep 25, 2018 and Jul 3, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Contamination1
- Contamination /Decontamination Problem1
- Material Fragmentation1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667669 ↗MalfunctionJan 18, 2023Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE BLADES BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16200156 ↗MalfunctionJul 22, 2020Contamination; Contamination /Decontamination Problem; Contamination
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10309661 ↗MalfunctionJan 11, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ADDITIONAL INFORMATION CONFIRMED ALL PIECES WERE RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8240697 ↗MalfunctionSep 25, 2018Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING A PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7907626 ↗
Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices
- NA 511.801Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL223 reports
- Formula 0375544000Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL98 reports
- NA 0277096325Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL95 reports
- NA 310.25Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL91 reports
- Arthrex® AR-8400TDArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL86 reports
- NA 0277096275Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL72 reports
- Arthrex® AR-7300DSArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL70 reports
- NA 0277096277Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL69 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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