PINNACLE 2217-60-015Recalls & reported problems
Depuy (Ireland) · PINNACLE INSTRUMENT CASE COMPLETE · Class 1
Quick summary
This DePuy Pinnacle instrument case is a surgical instrument tray used to hold and sterilize tools. The 31 reports mostly describe the trays peeling or delaminating, along with contamination or cleaning problems, plus cracked plastic, water stains, general wear and discoloration on old trays. None of the reports describe an injury or death, and in most cases nothing happened during surgery. There are no recalls naming 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295099239), received between Aug 17, 2020 and Jun 27, 2024 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (22 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
- Peeled/Delaminated22
- Contamination /Decontamination Problem21
- Naturally Worn8
- Crack6
- Material Discolored4
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT THE TRAYS ARE OLD AND DETERIORATING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629864 ↗MalfunctionJun 27, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT THE TRAYS ARE OLD AND DETERIORATING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629852 ↗MalfunctionJun 27, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT THE TRAYS ARE OLD AND DETERIORATING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629769 ↗MalfunctionJun 27, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT THE TRAYS ARE OLD AND DETERIORATING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629461 ↗MalfunctionJun 18, 2024Crack; Contamination /Decontamination Problem; Naturally Worn; Crack; Contamination /Decontamination Problem; Naturally Worn
IT WAS REPORTED THAT THERE WERE CRACKS AND WATER STAINS ON THE PINN INST CASE. THERE WAS NO DELAY IN SURGERY AND NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19564125 ↗MalfunctionJun 17, 2024Crack; Contamination /Decontamination Problem; Naturally Worn; Crack; Contamination /Decontamination Problem; Naturally Worn
IT WAS REPORTED THAT THE TRAYS HAVE CRACKED PLASTIC AND WATER STAINING. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19546780 ↗MalfunctionJun 13, 2024Crack; Contamination /Decontamination Problem; Crack; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE PLASTIC LAYERS IN TRAYS ARE CRACKED AND HAVE BECOME WATER STAINED. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19533235 ↗MalfunctionJun 13, 2024Crack; Contamination /Decontamination Problem; Naturally Worn; Crack; Contamination /Decontamination Problem; Naturally Worn
IT WAS REPORTED THAT PLASTIC LAYERS ARE CRACKED AND HAVE DEVELOPED WATER STAINS. NO DELAY, NO PATIENT CONSEQUENCES, NO LOTS DUE TO EXCESSIVE WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19531045 ↗MalfunctionJun 12, 2024Crack; Contamination /Decontamination Problem; Naturally Worn; Crack; Contamination /Decontamination Problem; Naturally Worn
IT WAS REPORTED THAT THE PLASTIC TRAY LAYERS HAVE CRACKED, DEVELOPED WATER STAINS AND ARE WORN. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19518973 ↗MalfunctionJun 11, 2024Crack; Contamination /Decontamination Problem; Illegible Information; Crack; Contamination /Decontamination Problem; Illegible Information
IT WAS REPORTED THAT THE TRAYS HAVE DEVELOPED CRACKS AND WATER STAINS IN PLASTIC LAYERS. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19515015 ↗MalfunctionMay 13, 2024Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO CONSEQUENCES, TRAYS NEED TO BE REPLACED AS THEY HAVE BECOME OLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298705 ↗MalfunctionMay 13, 2024Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO CONSEQUENCES, TRAYS NEED TO BE REPLACED AS THEY HAVE BECOME OLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298697 ↗MalfunctionMay 13, 2024Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO CONSEQUENCES, TRAYS NEED TO BE REPLACED AS THEY HAVE BECOME OLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298686 ↗MalfunctionMay 13, 2024Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED STATES, THAT THERE WAS NO CONSEQUENCES. TRAYS NEED TO BE REPLACED, AS THEY HAVE BECOME OLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298677 ↗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 14372877 ↗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 14372819 ↗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 14372783 ↗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 14372730 ↗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 14360854 ↗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 14360784 ↗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 14360669 ↗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 14360655 ↗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 14360636 ↗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 14360602 ↗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 14360544 ↗
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.