SUMMIT 2570-10-000Recalls & reported problems
Depuy (Ireland) · SUMMIT STERILE INSTRUMENT CASE COMPLETE · Class 1
All models of SUMMIT (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Summit sterile instrument case holds surgical instruments for sterilization. The 25 reports mostly describe the coating peeling or delaminating and plastic parts cracking and breaking, sometimes with problems getting the trays sterilized. The reports mention no deaths and no injuries, and 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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295143659), received between Nov 16, 2017 and May 8, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (17 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
- Peeled/Delaminated17
- Contamination /Decontamination Problem7
- Crack7
- Break5
- Appropriate Device Problem Term/Code Not Available2
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient3
- No Information2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Break; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE METAL IS DELAMINATING FROM PLASTIC, THE PLASTIC LIDS ARE BROKEN. THE PLASTIC IS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122711 ↗MalfunctionMar 4, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS PEELING WOULD NOT STERILIZE. THE EVENT DID NOT HAPPEN IN SURGERY. (B)(4) IS RELATED TO (B)(4). (B)(4) IS CREATED TO CAPTURE ADDITIONAL IPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505222 ↗MalfunctionMar 4, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS PEELING WOULD NOT STERILIZE. THE EVENT DID NOT HAPPEN IN SURGERY. (B)(4) IS RELATED TO (B)(4) IS CREATED TO CAPTURE ADDITIONAL IPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24504909 ↗MalfunctionFeb 27, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE TRAY INSERT WAS CRACKED AND SPD ASKED FOR IT TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24472783 ↗MalfunctionJan 16, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE PAN WAS PEELING DUE TO REPEATED USAGE AND WASHES. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094677 ↗MalfunctionJan 14, 2026Peeled/Delaminated
IT WAS REPORTED THAT PLASTIC WAS PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067801 ↗MalfunctionFeb 4, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL COMPLAINT ABOUT TRAYS CHIPPING, PEELING, CRACKING AND THE OUTER RUBBER PEELING OFF. IT WAS REPORTED THAT THE CHIPPING DID NOT HAPPEN IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21308458 ↗MalfunctionFeb 3, 2025Break; Crack; Peeled/Delaminated; Break; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE CONTAINER IS BROKEN AND CRACKED, AND THE INSERT IS PEELING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21293371 ↗MalfunctionJul 31, 2023Crack; Crack
IT WAS REPORTED THAT THE PLASTIC LEVELS IN PANS ARE CRACKED OR NOT ACCEPTABLE FOR PATIENT USE ANYMORE. SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17428330 ↗MalfunctionJul 31, 2023Crack; Crack
IT WAS REPORTED THAT THE PLASTIC LEVELS IN PANS ARE CRACKED OR NOT ACCEPTABLE FOR PATIENT USE ANYMORE. SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17426861 ↗MalfunctionMay 19, 2023Break; Break
SUMMIT TRAY INNER SHELL AND LID IS BROKEN (BOTH ARE PLASTIC PIECES).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16960031 ↗MalfunctionMay 12, 2022Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT TRAYS ARE BEING REJECTED BY THE HOSPITAL DUE TO STAINING AND BURNING OF THE ALUMINUM CASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14372883 ↗MalfunctionMay 12, 2022Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT TRAYS ARE BEING REJECTED BY THE HOSPITAL DUE TO STAINING AND BURNING OF THE ALUMINUM CASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14372872 ↗MalfunctionMay 11, 2022Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRAYS WERE BEING REJECTED BY THE HOSPITAL DUE TO STAINING AND BURNING OF THE ALUMINUM CASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14359770 ↗MalfunctionMay 11, 2022Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRAYS WERE BEING REJECTED BY THE HOSPITAL DUE TO STAINING AND BURNING OF THE ALUMINUM CASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14359760 ↗MalfunctionMay 11, 2022Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRAYS WERE BEING REJECTED BY THE HOSPITAL DUE TO STAINING AND BURNING OF THE ALUMINUM CASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14359717 ↗MalfunctionMay 11, 2022Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRAYS WERE BEING REJECTED BY THE HOSPITAL DUE TO STAINING AND BURNING OF THE ALUMINUM CASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14359701 ↗MalfunctionMay 11, 2022Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRAYS WERE BEING REJECTED BY THE HOSPITAL DUE TO STAINING AND BURNING OF THE ALUMINUM CASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14359402 ↗MalfunctionJan 6, 2021Peeled/Delaminated; Peeled/Delaminated
PROTECTIVE COATING ON TRAY IS PEELING AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11127076 ↗MalfunctionSep 26, 2019Peeled/Delaminated; Peeled/Delaminated
AFTER INSTRUMENT TRAY WAS USED IN SURGERY, STERILIZATION NOTICED A PLASTIC PART AT THE BOTTOM OF THE TRAY. IT IS PLASTIC COVERING METAL PARTS THAT IS PEELING OFF. NO PARTS WERE SEEN DURING SURGERY, SO NO HARM TO PATIENT. IT SEEMS THIS OCCURED AFTER SURGERY WHILE GOING THROUGH CLEANING PROCESS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9123914 ↗MalfunctionJul 10, 2019Break; Crack; Break; Crack
IT WAS REPORTED THAT THE INTERIOR INSTRUMENT PAN WAS BROKEN. NEEDS REPLACING. NO SURGERY. NO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8775327 ↗MalfunctionJul 10, 2019Break; Crack; Break; Crack
IT WAS REPORTED THAT THE INTERIOR INSTRUMENT PAN WAS BROKEN. NEEDS REPLACING. NO SURGERY. NO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8775324 ↗MalfunctionMay 7, 2019Peeled/Delaminated; Peeled/Delaminated
JUST BEFORE SURGERY, AS NURSES WERE OPENING THE INSTRUMENT TRAYS, THEY NOTICED THAT SOME PIECES OF PLASTIC COVERING THE METAL INSTRUMENT HOLDERS WERE PEELING OFF INSIDE THE TRAY. SURGEON REFUSED TO USE THAT INSTRUMENT TRAY AND THEY HAD TO OPEN ANOTHER TRAY. NO PATIENT HARM ,AS SURGERY HAD NOT STARTED AND NO SURGERY DELAY EITHER. DID THE EVENT OCCUR DURING STERILE PROCESSING? --> UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? --> UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8588166 ↗MalfunctionNov 16, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SUMMIT TAPERED INSTRUMENT CASE NOTED TO HAVE BLACK PLASTIC PEELING FROM THE AREA THAT HOLDS THE INSTRUMENTS IN PLACE.
Patient problems: No Information
MAUDE report 7039894 ↗MalfunctionNov 16, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SUMMIT TAPERED INSTRUMENT CASE REF 257010000 X 2 WERE NOTED TO HAVE BLACK PLASTIC PEELING FROM THE AREA THAT HOLDS THE INSTRUMENTS IN PLACE.
Patient problems: No Information
MAUDE report 7039889 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- n.a. 39501XKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6810Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 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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