NA 2598-07-420Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS TISSUE SPARING FEM CORE CASE 2 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy tissue sparing instrument tray holds surgical instruments. The 26 reports describe the black coating peeling off and brackets bending or chipping, with some noting corrosion or difficulty cleaning and sterilizing, with no deaths and no injuries. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295148371), received between Jul 9, 2018 and Apr 6, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated20
- Material Deformation5
- Break3
- No Apparent Adverse Event3
- Contamination /Decontamination Problem1
- Crack1
Patient problems
- No Consequences Or Impact To Patient16
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE TISSUE SPARING FEM CORE CASE 2 REPORTED WITHOUT ANY ALLEGATIONS. IT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE BLACK NYLON COATING OF RACK SECTION PEELING OFF, THREE BRACKET WERE DAMAGED, 2 WERE FOUND BENT AND THE OTHER ONE WAS CHIPPED. ADDITIONALLY, TO THE CONSISTENT DAMAGE EXHIBITED ON DEVICE, CORROSION PATTERNS WERE FOUND BOTH INSIDE AND OUTSIDE OF THE CUTTING SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790773 ↗MalfunctionApr 6, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE TISSUE SPARING FEM CORE CASE 2 REPORTED WITHOUT ANY ALLEGATIONS. IT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE BLACK NYLON COATING OF RACK SECTION PEELING OFF. ADDITIONALLY, ONE BRACKET WAS FOUND CHIPPED AND ANOTHER ONE WAS FOUND BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790764 ↗MalfunctionApr 6, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE TISSUE SPARING FEM CORE CASE 2 REPORTED WITHOUT ANY ALLEGATIONS. IT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE BLACK NYLON COATING OF RACK SECTION PEELING OFF. ADDITIONALLY, ONE BRACKET WAS FOUND CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790759 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051808 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051796 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051795 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051787 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051765 ↗MalfunctionMay 21, 2024Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT ALL TRAYS WERE PEELING AND OR CRACKED. HOSPITAL NEEDS TO REPLACE THESE ITEMS.
Patient problems: Insufficient Information
MAUDE report 19365103 ↗MalfunctionOct 19, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY IS PEELING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17966278 ↗MalfunctionFeb 25, 2020Break; Break
DURING A TOTAL HIP SURGERY, NURSES NOTICED THAT SOME OF THE PLASTIC COVERING THE INSTRUMENTS METAL HOLDERS IN THE TRAY WERE CHIPPING OFF. THEY FOUND A FEW PIECES AT THE BOTTOM OF THE TRAY. SURGEON WAS TOLD, LOOKED AT IT AND CONTINUED THE CASE AS SHE MENTIONED NOTHING CAME IN CONTACT WITH THE PATIENT. SHE HAS ASKED TO REPLACE THE TRAY. NO PATIENT HARM NOR SURGERY DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9750707 ↗MalfunctionAug 9, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated
WHILE CLEANING THE INSTR TRAYS, THE NOTICED THAT SOME PLASTICS PIECES WERE COMING OFF FROM THE INSTR.TRAYS. SOME INSTR SUPPORTS ARE COVERED BY PLASTIC AND AFTER YEARS IT STARTS PEELING OFF. NO DAMAGES TO PATIENT NOR SURGERY DELAYS AS IT WAS NOTICED AT STERILISATION ROOM AFTER CASES. PATIENT STATUS / OUTCOME / CONSEQUENCES? NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8880261 ↗MalfunctionMay 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
CUSTOMER HAS BEEN USING THE TRILOCK TRAYS FOR ABOUT 3 MONTHS. NOW THIS ISSUE IS OCCURING: THE TRAYS HAVE BEEN WASHED ABOUT 7 TIMES UP TO NOW AND AFTER THE STERILIZATION THERE IS A KIND OF "CHALK DUST" ON THE TRAYS. THIS HAPPENS ONLY WHEN WASHING THE TRILOCK TRAYS, ALL OTHER TRAYS BEHAVE NORMALLY. THE CAUSE IS UNKNOWN BUT THE "CHALK-LIKE LAYER" IS LOCATED ON THE INSIDE AND OUTSIDE OF THE ENTIRE TRAY. THE FEAR IS THAT PARTICLES OF THIS LAYER ARE ON THE INSTRUMENTS AND CAN COME IN CONTACT WITH THE PATIENT. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8592228 ↗MalfunctionApr 10, 2019Peeled/Delaminated; Peeled/Delaminated
PRODUCT CODE- (B)(4). TISSUE SPARING FEM CORE CASE 2-LOT PV0179839- PEELING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8499268 ↗MalfunctionApr 10, 2019Break; Break
PRODUCT CODE-(B)(4). ¿ TISSUE SPARING FEM CORE CASE 2-LOT D43CR4-FAILURE DELAMINATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8499244 ↗MalfunctionMar 29, 2019Peeled/Delaminated; Peeled/Delaminated
THE MATERIAL IN THE CORE CASES IS PEELING, IT'S NOT COMPLYING ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8465394 ↗MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
THIS IS NOT A COMPLAINT THAT REFERS TO A SPECIFIC CASE. THE STERILIZATION DEPT COMPLAINED ABOUT THEIR TRICKLOCK INSTRUMENT CASES. THE INSTR HOLDERS ARE COVERED WITH A PLASTIC PIECE THAT IS THERE TO PROTECT. UNFORTUNATELY,WITH TIME AND MANY STERILIZATION PROCESSES THIS PLASTIC IS PEALING OF, SO THEY FEEL THE TRAYS SHOULD BE REPLACED AS THEY WILL STOP STERILIZING THEM SOON. THIS HAS NO AFFECT ON PATIENTS FOR NOW AND DOES NOT EXTEND SURGERIES TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197804 ↗MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
THIS IS NOT A COMPLAINT THAT REFERS TO A SPECIFIC CASE. THE STERILIZATION DEPT COMPLAINED ABOUT THEIR TRICKLOCK INSTRUMENT CASES. THE INSTR HOLDERS ARE COVERED WITH A PLASTIC PIECE THAT IS THERE TO PROTECT. UNFORTUNATELY,WITH TIME AND MANY STERILIZATION PROCESSES THIS PLASTIC IS PEALING OF, SO THEY FEEL THE TRAYS SHOULD BE REPLACED AS THEY WILL STOP STERILIZING THEM SOON. THIS HAS NO AFFECT ON PATIENTS FOR NOW AND DOES NOT EXTEND SURGERIES TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197803 ↗MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
THIS IS NOT A COMPLAINT THAT REFERS TO A SPECIFIC CASE. THE STERILIZATION DEPT COMPLAINED ABOUT THEIR TRICKLOCK INSTRUMENT CASES. THE INSTR HOLDERS ARE COVERED WITH A PLASTIC PIECE THAT IS THERE TO PROTECT. UNFORTUNATELY,WITH TIME AND MANY STERILIZATION PROCESSES THIS PLASTIC IS PEALING OF, SO THEY FEEL THE TRAYS SHOULD BE REPLACED AS THEY WILL STOP STERILIZING THEM SOON. THIS HAS NO AFFECT ON PATIENTS FOR NOW AND DOES NOT EXTEND SURGERIES TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197792 ↗MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
THIS IS NOT A COMPLAINT THAT REFERS TO A SPECIFIC CASE. THE STERILIZATION DEPT COMPLAINED ABOUT THEIR TRICKLOCK INSTRUMENT CASES. THE INSTR HOLDERS ARE COVERED WITH A PLASTIC PIECE THAT IS THERE TO PROTECT. UNFORTUNATELY,WITH TIME AND MANY STERILIZATION PROCESSES THIS PLASTIC IS PEALING OF, SO THEY FEEL THE TRAYS SHOULD BE REPLACED AS THEY WILL STOP STERILIZING THEM SOON. THIS HAS NO AFFECT ON PATIENTS FOR NOW AND DOES NOT EXTEND SURGERIES TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197787 ↗MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
THIS IS NOT A COMPLAINT THAT REFERS TO A SPECIFIC CASE. THE STERILIZATION DEPT COMPLAINED ABOUT THEIR TRICKLOCK INSTRUMENT CASES. THE INSTR HOLDERS ARE COVERED WITH A PLASTIC PIECE THAT IS THERE TO PROTECT. UNFORTUNATELY,WITH TIME AND MANY STERILIZATION PROCESSES THIS PLASTIC IS PEALING OF, SO THEY FEEL THE TRAYS SHOULD BE REPLACED AS THEY WILL STOP STERILIZING THEM SOON. THIS HAS NO AFFECT ON PATIENTS FOR NOW AND DOES NOT EXTEND SURGERIES TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197783 ↗MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
THIS IS NOT A COMPLAINT THAT REFERS TO A SPECIFIC CASE. THE STERILIZATION DEPT COMPLAINED ABOUT THEIR TRICKLOCK INSTRUMENT CASES. THE INSTR HOLDERS ARE COVERED WITH A PLASTIC PIECE THAT IS THERE TO PROTECT. UNFORTUNATELY,WITH TIME AND MANY STERILIZATION PROCESSES THIS PLASTIC IS PEALING OF, SO THEY FEEL THE TRAYS SHOULD BE REPLACED AS THEY WILL STOP STERILIZING THEM SOON. THIS HAS NO AFFECT ON PATIENTS FOR NOW AND DOES NOT EXTEND SURGERIES TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197762 ↗MalfunctionOct 26, 2018Peeled/Delaminated; Peeled/Delaminated
THE MATERIAL IN THE CORE CASES IS PEELING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8010902 ↗MalfunctionAug 8, 2018Peeled/Delaminated; Peeled/Delaminated
PANS ARE PEELING AND NEED TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7761917 ↗MalfunctionAug 8, 2018Peeled/Delaminated; Peeled/Delaminated
PANS ARE PEELING AND NEED TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7761894 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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