PINNACLE 2217-60-013Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL SHELL TRAY 47/48 - 65/66 · 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 10603295099222), received between Aug 17, 2020 and Apr 27, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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
- Contamination /Decontamination Problem2
- Peeled/Delaminated2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Peeled/Delaminated
IT WAS REPORTED THAT AFTER REPEATED USAGE THE PAN GRADUALLY STARTED BREAKING DOWN AND WAS NO LONGER COMPLIANT. IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002309 ↗MalfunctionJun 10, 2025Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
CONSIGNMENT REPLACEMENT TRAYS REQUIRED DUE TO STERILISATION CONCERNS FOR PINNACLE TRIAL SHELLS, SCREW TRAY, X BACK GRATERS QUICKSET GRATERS AND SHELL TRIALS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176447 ↗MalfunctionNov 29, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE BOTTOM OF THE TRAYS ARE FALLING APART OVER TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12883611 ↗MalfunctionAug 17, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT A LOANER SET OF INSTRUMENTS WAS RECEIVED BACK FROM A HOSPITAL THAT CONTAINED RESIDUAL DEBRIS AND HAD TO BE RETURNED TO THE SITE FOR ADDITIONAL CLEANING BY THEIR STERILE PROCESSING DEPARTMENT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10417415 ↗
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.