Formula 0375564000Recalls & 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
- 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 07613327061895), received between Apr 15, 2019 and Jul 31, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure3
- Expiration Date Error1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2024Smoking; Smoking
IT WAS REPORTED THAT THE DEVICE WAS SMOKING.
Patient problems: Insufficient Information
MAUDE report 19876338 ↗MalfunctionApr 5, 2024Activation Failure; Activation Failure
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MOVE THE SHAVER BLADE FORWARDS OR BACKWARDS. SWITCHING THE DEVICE ON AND OFF, CHANGING THE BLADE AND CHANGING THE SHAVER HANDPIECE, DID NOT BRING ANY IMPROVEMENT. AFTER RESTART, 3 DIFFERENT ERROR MESSAGES WERE DISPLAYED. THE DEVICE DIDN'T TURN ON AGAIN. SURGERY WAS CANCELLED. A NEW SURGERY WILL NOT BE SCHEDULED INITIALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055500 ↗MalfunctionApr 5, 2024Activation Failure; Activation Failure
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MOVE THE SHAVER BLADE FORWARDS OR BACKWARDS. SWITCHING THE DEVICE ON AND OFF, CHANGING THE BLADE AND CHANGING THE SHAVER HANDPIECE, DID NOT BRING ANY IMPROVEMENT. AFTER RESTART, 3 DIFFERENT ERROR MESSAGES WERE DISPLAYED. THE DEVICE DIDN'T TURN ON AGAIN. SURGERY WAS CANCELLED. A NEW SURGERY WILL NOT BE SCHEDULED INITIALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055320 ↗MalfunctionApr 5, 2024Activation Failure; Activation Failure
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO MOVE THE SHAVER BLADE FORWARDS OR BACKWARDS. SWITCHING THE DEVICE ON AND OFF, CHANGING THE BLADE AND CHANGING THE SHAVER HANDPIECE, DID NOT BRING ANY IMPROVEMENT. AFTER RESTART, 3 DIFFERENT ERROR MESSAGES WERE DISPLAYED. THE DEVICE DIDN'T TURN ON AGAIN. SURGERY WAS CANCELLED. A NEW SURGERY WILL NOT BE SCHEDULED INITIALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055194 ↗MalfunctionApr 15, 2019Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT HAD BEEN USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8515197 ↗
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.