NA 2611-20-000Recalls & reported problems
Depuy Orthopaedics, Inc. · CORE CASE 2 INSTRUMENT CASE COMPLETE · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295149200), received between Jun 29, 2022 and Feb 4, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (4 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
- Crack4
- Peeled/Delaminated4
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2025Break; Crack; Peeled/Delaminated; Break; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL WAS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305173 ↗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 21294003 ↗MalfunctionMay 21, 2024Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT ALL TRAYS WERE PEELING AND OR CRACKED.
Patient problems: Insufficient Information
MAUDE report 19365095 ↗MalfunctionJun 29, 2022Break; Crack; Peeled/Delaminated; Break; Crack; Peeled/Delaminated
ON (B)(6) 2022 THE SPD DEPARTMENT AT NORTH CHICAGO VA (UCN 400422) DENIED THE DELIVERY OF SIX TRAYS. THE HOSPITAL STAFF OBSERVED DAMAGE ON THE BRACKETS WHICH HOLD THE INSTRUMENTS IN PLACE WITHIN THE GRAPHIC CASES AS WELL AS THE GENERAL CONDITION OF THE PLASTIC TRAY INSERTS. THIS ISSUE WAS IDENTIFIED ON JUNE 3RD AND REPLACEMENT TRAYS WERE DELIVERED ON JUNE 6TH FOR THE CASE THAT WAS SCHEDULED ON JUNE, 8TH. CONSULTANT CONFIRMED THAT THERE WAS NO IMPACT OR DELAY IN SURGICAL SCHEDULE DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14855369 ↗
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
- INSTRUMENT 6541-9-109Howmedica Osteonics Corp. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 11580AKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.