Formula 0375565000Recalls & reported problems
Stryker Corporation · [Tomcat Cutter, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight] · Class 1
- 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 07613327061932), received between Jul 20, 2018 and Nov 21, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation2
- Device Contaminated During Manufacture or Shipping1
- Device Unsafe to Use in Environment1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 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 20753851 ↗MalfunctionNov 21, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 20753702 ↗MalfunctionJan 4, 2022Device Unsafe to Use in Environment; Device Contaminated During Manufacture or Shipping; Device Unsafe to Use in Environment; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13158455 ↗MalfunctionMay 28, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8647087 ↗MalfunctionJul 20, 2018Break
IT WAS REPORTED THAT A PIECE OF THE SHAVER BROKE OFF INSIDE THE PATIENT. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7706371 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.