Formula 0375532000Recalls & reported problems
Stryker Corporation · [Resector 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327061833), received between Sep 24, 2020 and Oct 23, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Material Fragmentation2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE ARTHROSCOPY, WHILE PERFORMING THE BURRING PROCESS, THE BLADE (INNER SHEATH) FRACTURED. THE COMPONENT WAS COMPLETELY REMOVED AND DID NOT CAUSE ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373953 ↗MalfunctionJul 1, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE RESECTOR BLADE BROKE OFF INSIDE OF THE PATIENT'S ANKLE. THERE WERE SOME DELAYS AS THEY TRIED TO RETRIEVE THE PIECE.
Patient problems: Insufficient Information
MAUDE report 19651994 ↗MalfunctionMar 30, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16649344 ↗MalfunctionOct 21, 2022Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15655893 ↗MalfunctionSep 24, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15475768 ↗MalfunctionMar 11, 2021Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11467666 ↗MalfunctionMar 11, 2021Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11467663 ↗MalfunctionSep 24, 2020Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE OFF DURING THE PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED, THE TIP DID NOT BREAK INSIDE OF THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10580425 ↗
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.