QUICKSET 2440-00-511Recalls & reported problems
Depuy (Ireland) · QUICKSET STD TISSUE PROTECTOR · Class 1
All models of QUICKSET (66)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy QUICKSET standard tissue protector is a surgical sleeve used to protect tissue during orthopedic procedures. The 48 reports describe sleeves that wear down, break, crack, twist, bend or discolor, sometimes with the protective sheath peeling away; most mention no effect on the patient and no surgical delay. No deaths or injuries are described. 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
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295123804), received between Mar 20, 2018 and Sep 10, 2026 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn20
- Break15
- Material Twisted/Bent12
- Crack8
- Material Discolored7
- Material Deformation4
- Appropriate Device Problem Term/Code Not Available2
- Degraded2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Consequences Or Impact To Patient14
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721851 ↗MalfunctionJan 24, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SLEEVES WERE WORN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18570530 ↗MalfunctionJan 24, 2024Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY ? WAS THERE A SURGERY DELAY? IF YES, WHAT WAS THE DURATION OF THE DELAY - NO DELAY. B. WAS THERE ANY ADVERSE CONSEQUENCES/SYMPTOMS THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO CONSEQUENCES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18570205 ↗MalfunctionJan 22, 2024Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18555099 ↗MalfunctionJan 22, 2024Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18555044 ↗MalfunctionJan 22, 2024Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18555028 ↗MalfunctionJan 22, 2024Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18555011 ↗MalfunctionDec 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE GRATOR PROTECTOR SHEATH IS PEELING OFF.
Patient problems: Insufficient Information
MAUDE report 18290239 ↗MalfunctionDec 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE GRATOR PROTECTOR SHEATH IS PEELING OFF.
Patient problems: Insufficient Information
MAUDE report 18290230 ↗MalfunctionDec 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE GRATOR PROTECTOR SHEATH IS PEELING OFF.
Patient problems: Insufficient Information
MAUDE report 18290225 ↗MalfunctionDec 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE GRATOR PROTECTOR SHEATH IS PEELING OFF.
Patient problems: Insufficient Information
MAUDE report 18290223 ↗MalfunctionDec 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE GRATOR PROTECTOR SHEATH IS PEELING OFF.
Patient problems: Insufficient Information
MAUDE report 18290220 ↗MalfunctionDec 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE GRATOR PROTECTOR SHEATH IS PEELING OFF.
Patient problems: Insufficient Information
MAUDE report 18290212 ↗MalfunctionNov 13, 2023Crack; Naturally Worn; Crack; Naturally Worn
IT WAS REPORTED THAT THE QUICKSET STD TISSUE PROTECTORS ARE DAMAGED AND STARTING TO FLAKE AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18118214 ↗MalfunctionNov 13, 2023Crack; Naturally Worn; Crack; Naturally Worn
IT WAS REPORTED THAT THE QUICKSET STD TISSUE PROTECTORS ARE DAMAGED AND STARTING TO FLAKE AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18118196 ↗MalfunctionNov 8, 2023Break; Break
IT WAS REPORTED THAT TISSUE PROTECTOR SLEEVE IS SHEDDING OUTER LAYER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18091569 ↗MalfunctionOct 19, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE WHITE STD TISSUE PROTECTOR STARTED TO CRACK AND FLAKE OFF. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17971237 ↗MalfunctionOct 19, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE WHITE STD TISSUE PROTECTOR STARTED TO CRACK AND FLAKE OFF. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17971234 ↗MalfunctionOct 19, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE WHITE STD TISSUE PROTECTOR STARTED TO CRACK AND FLAKE OFF. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17971233 ↗MalfunctionOct 19, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE WHITE STD TISSUE PROTECTOR STARTED TO CRACK AND FLAKE OFF. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17971232 ↗MalfunctionOct 19, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE WHITE STD TISSUE PROTECTOR STARTED TO CRACK AND FLAKE OFF. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17971231 ↗MalfunctionOct 19, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE WHITE STD TISSUE PROTECTOR STARTED TO CRACK AND FLAKE OFF. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17971228 ↗MalfunctionDec 15, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE QUICKSET TISSUE PROTECTORS ARE STARTING TO FLAKE AND NEED TO BE REPLACED. THE CLEAR PLASTIC COATING IS FLAKING OFF IN SMALL STRIPS. NO DELAY OR ADVERSE EVENT WAS EXPERIENCED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13009772 ↗MalfunctionDec 15, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE QUICKSET TISSUE PROTECTORS ARE STARTING TO FLAKE AND NEED TO BE REPLACED. THE CLEAR PLASTIC COATING IS FLAKING OFF IN SMALL STRIPS. NO DELAY OR ADVERSE EVENT WAS EXPERIENCED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13009754 ↗MalfunctionOct 6, 2021Material Discolored; Naturally Worn; Material Discolored; Naturally Worn
GRATERS ARE RUSTED. GRATER HANDLES ARE OLD AND PITTED. HANDLE SLEEVES ARE WORN AND YELLOW. STAFF REFUSED TO PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12583906 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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