Formula 0375562000Recalls & 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
Quick summary
This Stryker Formula shaver blade is a surgical cutter used in arthroscopic procedures. Reports mostly describe blades breaking during use and foreign material found inside unopened sterile packaging. There are 23 reports naming its identifier, with no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327061871), received between Jul 17, 2018 and Mar 18, 2026 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Break” (15 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
- Break15
- Material Fragmentation4
- Device Contaminated During Manufacture or Shipping3
- Component Missing1
- Contamination /Decontamination Problem1
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information8
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE SHAVER BLADE HAD SMALL PIECES OF PLASTIC INSIDE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626356 ↗MalfunctionFeb 5, 2026Material Fragmentation
IT WAS REPORTED THERE WAS AN ISOLATED INCIDENT WITH NO SERIOUS CONSEQUENCES FOR THE PATIENT. THERE WAS BREAKAGE OF A RESECTOR BLADE REFERENCE 0375-562-000, BATCH NUMBER 25157CE2. THE PROBLEM WAS RESOLVED BY USING A DIFFERENT BLADE. THE SHAVER BROKE ON THE MORNING OF JANUARY 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274157 ↗MalfunctionFeb 5, 2026Material Fragmentation
IT WAS REPORTED THERE WAS AN ISOLATED INCIDENT WITH NO SERIOUS CONSEQUENCES FOR THE PATIENT. THERE WAS BREAKAGE OF A RESECTOR BLADE REFERENCE (B)(4), BATCH NUMBER 25157CE2. THE PROBLEM WAS RESOLVED BY USING A DIFFERENT BLADE. THE SHAVER BROKE ON THE MORNING OF (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274135 ↗MalfunctionOct 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE SCRUB TECH WAS OBSERVING THE PACKAGING WHEN THEY SAW AN EYELASH INSIDE THE STRYKER RESECTOR. THE PACKAGING WAS NOT OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23270891 ↗MalfunctionOct 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY, THE DRILL BIT BROKE, REQUIRING THE USE OF ANOTHER DRILL BIT AND CLEANING TO REMOVE METAL DEBRIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23240041 ↗MalfunctionSep 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20139851 ↗MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581792 ↗MalfunctionApr 17, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16753846 ↗MalfunctionApr 13, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16735122 ↗MalfunctionApr 13, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16734770 ↗MalfunctionJun 9, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS ABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14642633 ↗MalfunctionMay 18, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE DID NOT FALL INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14430383 ↗MalfunctionJan 11, 2022Break; Break
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 13229084 ↗InjuryNov 24, 2021Break; Component Missing; Break; Component Missing
IT WAS REPORTED THAT THE DEVICE POTENTIALLY BROKE INSIDE THE PATIENT AND WAS NOT ABLE TO BE REMOVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12870384 ↗MalfunctionMar 23, 2021Break; Material Deformation; Material Deformation
IT WAS REPORTED THAT A PIECE OF THE DEVICE CHIPPED OFF DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11555384 ↗MalfunctionMar 10, 2021Break; Break
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 11457057 ↗MalfunctionJan 25, 2021Break; Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE GOT DAMAGED DURING THE PROCEDURE AND THERE WAS A SURGICAL DELAY OF 30 MINUTES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11225153 ↗MalfunctionDec 22, 2020Break; Break
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 11060924 ↗MalfunctionDec 22, 2020Break; Break
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 11060894 ↗MalfunctionDec 16, 2020Break; Break
IT WAS REPORTED THAT THE DISTAL END OF THE INNER HOUSING CAME OFF OF THE DEVICE. NOTE, IT DID NOT COME OFF INSIDE OF THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11016031 ↗MalfunctionJul 22, 2020Break; Fracture; Fracture
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10309595 ↗MalfunctionAug 21, 2019Break
IT WAS REPORTED THAT TIP BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8915531 ↗MalfunctionJul 17, 2018Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN STERILE PACKAGING
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7694095 ↗
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- Arthrex® AR-7300DSArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL70 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.