PINNACLE 2220-00-130Recalls & reported problems
Depuy (Ireland) · PINNACLE SCREW SET CASE · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle screw set case is a plastic tray used to hold orthopedic screws. The 33 reports mostly describe the plastic peeling or delaminating from inside the tray, which some say left it no longer able to be sterilized; a few also mention discoloration, contamination, or a break. No deaths or injuries were reported. Reports rose recently, with 14 in the last 12 months versus 6 in the prior 12. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295424208), received between Apr 26, 2023 and Apr 28, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (32 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/Delaminated32
- Contamination /Decontamination Problem4
- Material Discolored4
- Break1
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT PLASTIC WAS PEELING OFF THE INSIDE OF THE TRAY. THERE WAS NO DELAY TO A PROCEDURE. NO HARM TO PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25022431 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN SCREW TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427591 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN SCREW TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427590 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN SCREW TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427585 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN SCREW TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427584 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN SCREW TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427580 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN SCREW TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427569 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN SCREW TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427568 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN SCREW TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427567 ↗MalfunctionFeb 10, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE COATING IN THE TRAY WAS PEELING AND THERE WAS PAINT PEELING FROM THE SIDE OF THE TRAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305965 ↗MalfunctionNov 21, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE COATING ON DIVIDERS FOR INSTRUMENT SEATING WERE PEELING AND HOSPITALS WERE REJECTING THE DEVICES DUE TO CONTAMINATION LIABILITY. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617862 ↗MalfunctionNov 20, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT PAINT FALLING OFF PAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23607369 ↗MalfunctionNov 6, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC INSIDE THE SCREW SET PAN IS DELAMINATING AND FLAKING OFF. SPD SAYS THE TRAY NEEDS TO BE REPLACED. NO HARM TO PATIENT. NO DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485458 ↗MalfunctionAug 22, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS PORTED THAT PLASTIC COATING INSIDE THE PAN WAS DELAMINATED AND FLAKING OFF. THERE WAS NO HARM TO PATIENT AND THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873743 ↗MalfunctionAug 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC HAS DELAMINATED FROM THE INSIDE OF THE TRAYS AND SPD WILL NOT STERILIZE THEM. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689454 ↗MalfunctionAug 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC HAS DELAMINATED FROM THE INSIDE OF THE TRAYS AND SPD WILL NOT STERILIZE THEM. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689435 ↗MalfunctionJul 9, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC IS COMING OFF THE INSIDE OF THE SCREW SET AND GRATER HEADS TRAYS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22462490 ↗MalfunctionJul 9, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC ON THE INSIDE OF THE SCREW AND GRATER PANS IS DELAMINATING AND SPD SAYS THEY HAVE TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460491 ↗MalfunctionJul 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAN WAS PEELING, THE PINNACLE SCREW SET CASE WAS PEELING, 1 UNKNOWN PRODUCT WAS CRACKED AND ANOTHER UNKNOWN PRODUCT WAS ALSO PEELING. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378549 ↗MalfunctionJun 6, 2024Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS NEED TO BE REPLACED DUE TO DISCOLORATION AND FLAKING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19477201 ↗MalfunctionMay 14, 2024Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS NEED TO BE REPLACED DUE TO DISCOLORATION AND FLAKING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19312988 ↗MalfunctionMay 14, 2024Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS NEED TO BE REPLACED DUE TO DISCOLORATION AND FLAKING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19312986 ↗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 19298623 ↗MalfunctionMar 20, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRAYS ARE CHIPPING FLAKES OFF. THE HOSPITAL IS DEEMING THEM CONTAMINATED AFTER STERILE PROCESS AND UNFIT FOR PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942131 ↗MalfunctionMar 20, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRAYS ARE CHIPPING FLAKES OFF. THE HOSPITAL IS DEEMING THEM CONTAMINATED AFTER STERILE PROCESS AND UNFIT FOR PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942099 ↗
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
- Calibrate CLCCXSIMPAAlphatec Spine, 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
- n.a. 39501A2Karl 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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