Formula 0375544000Recalls & 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
Quick summary
This Stryker Aggressive Plus Cutter arthroscopic shaver blade has 103 adverse event reports, with 10 injuries and no deaths. Most describe the blade or tip breaking or fracturing during surgery, sometimes leaving fragments in the joint that surgeons retrieved; others mention contamination or packaging problems. No recalls name this device. Reports rose from 9 in the prior 12 months to 16 in the last 12 months.
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
- 98
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 07613327061789), received between Jun 12, 2018 and Jun 23, 2026 — classified as 10 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Break” (51 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
- Break51
- Material Fragmentation28
- Contamination /Decontamination Problem7
- Device Contaminated During Manufacture or Shipping7
- Packaging Problem4
- Delivered as Unsterile Product3
- Device Contamination with Chemical or Other Material3
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Known Impact Or Consequence To Patient34
- Insufficient Information12
- No Consequences Or Impact To Patient6
- Foreign Body In Patient5
- Burn(s)1
- Cartilage damage1
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2026Break; Material Fragmentation
IT WAS REPORTED THAT DURING SHAVER OPERATION, THE TIP FRACTURED AND FELL INTO THE PATIENT¿S SHOULDER JOINT CAVITY. THE SURGEON RETRIEVED THE BROKEN FRAGMENTS AND REMOVED THEM PROMPTLY. NO MISSING PARTS OF THE CUTTER HEAD WERE FOUND AFTER INSPECTION, AND A NEW DEVICE WAS USED THEREAFTER. THIS INCIDENT PROLONGED THE OPERATIVE DURATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601879 ↗MalfunctionFeb 24, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT AFTER OPENING STERILE PACKAGE AND INSPECTING ITEM, SOME TYPE OF MATERIAL WAS OBSERVED IN THE JAWS OF THE CUTTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436987 ↗MalfunctionFeb 24, 2026Material Fragmentation
IT WAS REPORTED THAT IT WAS DISCOVERED THAT ONE TOOTH WAS MISSING FROM THE CTR. THERE WAS IMMEDIATELY FILM AND EXTENSIVE RINSING, AND FILTER TO SEARCH FOR NO RESIDUE. THE FILM INDICATED THERE WAS NO RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436985 ↗MalfunctionFeb 3, 2026Material Fragmentation
IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE FORMULA AGGRESSIVE PLUS CUTTER CAME APART IN THE PATIENT. THE SURGEON FISHED IT OUT WITH A GRASPER SO NOTHING WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24252876 ↗MalfunctionFeb 3, 2026Material Fragmentation
IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE FORMULA AGGRESSIVE PLUS CUTTER CAME APART IN THE PATIENT. THE SURGEON FISHED IT OUT WITH A GRASPER SO NOTHING WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24252860 ↗MalfunctionJan 30, 2026Material Fragmentation
IT WAS REPORTED THAT THE SHAVER ATTACHMENT FRACTURED AT THE CUTTING BLADE, RENDERING IT UNUSABLE. A SPARE DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE MEDICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225035 ↗MalfunctionJan 30, 2026Material Fragmentation
IT WAS REPORTED THAT THE SHAVER ATTACHMENT FRACTURED AT THE CUTTING BLADE, RENDERING IT UNUSABLE. A SPARE DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE MEDICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24224039 ↗MalfunctionJan 29, 2026Material Fragmentation
IT WAS REPORTED THAT THE SHAVER ATTACHMENT FRACTURED AT THE CUTTING BLADE, RENDERING IT UNUSABLE. A SPARE DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE MEDICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211273 ↗MalfunctionJan 8, 2026Material Fragmentation
IT WAS REPORTED THAT THE DOCTOR WAS SHAVING THE SHOULDER ARTHROSCOPICALLY AND THE TIP OF THE SHAVER BROKE OFF IN THE SHOULDER. IT WAS EASILY RETRIEVED WITH THE GRASPER, AND THE SHAVER WAS EVALUATED BY TEAM MEMBERS AFTER PASSED OFF THE FIELD TO ENSURE IT WAS INTACT. AN X-RAY WAS TAKEN TO BE EXTRA SURE AND WAS READ NEGATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24011895 ↗MalfunctionJan 7, 2026Material Fragmentation
IT WAS REPORTED THAT ONE AGGRESSIVE PLUS SHAVE WAS USED AND IT BROKE AT THE TIP DURING SURGERY. THE PRODUCT WAS USED ON A PATIENT AND WAS THEREFORE DISCARDED. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995823 ↗MalfunctionDec 2, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGICAL CAVITY WAS INSPECTED AND IT WAS FOUND THAT THE INTERNAL DISTAL PORTION OF THE BLADE HAD FRACTURED AND REMAINED INSIDE THE CAVITY. THE FRAGMENT WAS CAREFULLY REMOVED WITH FORCEPS, AND IT WAS SUBSEQUENTLY VERIFIED THAT NO RESIDUES REMAINED AND THAT NO INJURIES WERE PRESENT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23698179 ↗MalfunctionOct 21, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE INNER TUBE OF THE SHAVER TIP WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350641 ↗MalfunctionOct 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THAT INSIDE THE STERILE PACKAGE, THERE IS A SMALL RED OBJECT IN THE TEETH OF THE SHAVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23318813 ↗MalfunctionSep 30, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SHAVER TIP BROKE OFF. ALL PIECES ARE ACCOUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23187336 ↗MalfunctionSep 3, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SHAVER WAS BEING USED ON AN ARTHROSCOPY TO RESECT SOFT TISSUE WHEN THE INNER SHAFT BROKE OFF AND FELL INTO THE PATIENT'S JOINT. THE SHAVER TIP AND HANDPIECE WERE OPERATING NORMALLY UNTIL THIS INCIDENT. IT TOOK 30-40 MINUTES TO RETRIEVE THE BROKEN PIECE. ALL BROKEN PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956204 ↗MalfunctionAug 12, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT IN ARTHROSCOPIC SURGERY, A BLADE WAS USED FOR JOINT CAVITY CLEANING, AND IT WAS FOUND THAT THE BLADE ORIGINALLY HAD 8 TEETH, BUT ONE TOOTH WAS MISSING, MAKING IT IMPOSSIBLE TO DETERMINE WHETHER IT WAS BROKEN OR WORN. HOWEVER, IT WAS NOT FOUND IN THE JOINT CAVITY UNDER X-RAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22788343 ↗MalfunctionApr 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE OR FOUND A RED SPECK OF PAINT ON THE SIDE OF THE CUTTER BLADE AS THEY WERE PULLING IT FOR USE ON A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21904666 ↗MalfunctionApr 4, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED. AN X-RAY CONFIRMED NO PIECES WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21777793 ↗MalfunctionDec 19, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RECOVERED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20982341 ↗MalfunctionNov 15, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED WITH USE OF X-RAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695085 ↗MalfunctionSep 25, 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 20306649 ↗MalfunctionSep 25, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301937 ↗MalfunctionSep 13, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20218105 ↗MalfunctionSep 13, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20215158 ↗MalfunctionAug 28, 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 20092329 ↗
Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices
- NA 511.801Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL223 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
- NA 0277096326Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL60 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.