ACTIS 2010-04-200Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH CASE BASE · Class 1
Quick summary
This DePuy Actis broach case base is the sterilization tray used to hold surgical instruments. There are 74 adverse event reports, mostly describing the tray's surface peeling or flaking inside, with some cracking, breaking or worn-off paint, and occasionally trial stem pieces detaching. No deaths and no injuries were reported, and no recalls name this device. Reports in the past 12 months (30) are higher than the 12 months before (12).
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
- 66
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10603295393887), received between Oct 17, 2022 and Sep 8, 2026 — classified as 66 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (53 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/Delaminated53
- Crack11
- Break5
- Naturally Worn4
- No Apparent Adverse Event3
- Contamination /Decontamination Problem2
- Detachment of Device or Device Component2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674595 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313487 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313484 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313479 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313282 ↗MalfunctionMay 15, 2026Detachment of Device or Device Component
IT WAS REPORTED THE MALFUNCTION DID NOT HAPPEN IN SURGERY. ACTIS TRAY IS MISSING HEAD TRIAL POST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25186560 ↗MalfunctionMay 5, 2026Peeled/Delaminated
IT WAS REPORTED THAT PAINT WAS CHIPPED, MISSING HEAD TRIAL PEGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081597 ↗MalfunctionApr 27, 2026Peeled/Delaminated
IT WAS REPORTED THAT ¿MDR" NOTICED THE PAN WAS WORN AND PEELING DURING CLEANING. THE EVENT WAS NOT RELATED TO SURGERY. NO PATIENT OR USER HARM WAS REPORTED. NO DELAY OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003873 ↗MalfunctionApr 16, 2026Peeled/Delaminated
IT WAS REPORTED THAT THERE WAS DELAMINATING TRAY. SPD WON'T STERILIZE. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24902371 ↗MalfunctionApr 16, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE PLASTIC HOLDING THE BROACHES WAS WORN AND THE HOSPITAL IS SAYING THE TRAYS CAN'T BE STERILIZED. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897781 ↗MalfunctionApr 16, 2026Peeled/Delaminated
IT WAS REPORTED THAT THERE WAS DELAMINATING TRAY. SPD WON'T STERILIZE. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24893344 ↗MalfunctionApr 16, 2026Peeled/Delaminated
IT WAS REPORTED THAT THERE WAS DELAMINATING TRAY. SPD WON'T STERILIZE. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24893341 ↗MalfunctionMar 23, 2026Material Deformation
IT WAS REPORTED THAT THE TRAY IS BENT/DAMAGED AND RISKS STERILITY DUE TO SHARP EXPOSED EDGES. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661501 ↗MalfunctionMar 4, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY PAINT WAS CHIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513366 ↗MalfunctionFeb 19, 2026Break; Peeled/Delaminated
IT WAS REPORTED THAT TRAY WAS BROKEN DOWN, MISSING POSTS FOR HEAD TRIALS AND LOST A LOT OF PAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397532 ↗MalfunctionFeb 11, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316242 ↗MalfunctionFeb 2, 2026Peeled/Delaminated
IT WAS CONFIRMED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT THA FOR OA WITH THE PRODUCTS IN QUESTION. BEFORE THE SURGERY, THE HOSPITAL FOUND A LOT OF BLACK FRAGMENTS IN CASE. THE BLACK PLASTIC PART IN CASE WAS PEELED OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PRODUCT IN QUESTION IS A CONSIGNED ITEM, SO IT APPEARS TO HAVE BEEN REPEATEDLY WASHED AND STERILIZED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24241117 ↗MalfunctionDec 3, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ACTIS BROACH TRAY OLD AND PEELING. ACCOUNT IS REJECTING FURTHER USE. CONTENTS OF TRAY ARE FINE. JUST ACTUAL TRAY NEEDS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704435 ↗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 23617790 ↗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 23617762 ↗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 23617616 ↗MalfunctionNov 18, 2025Crack; Contamination /Decontamination Problem; Crack; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE PANS ARE OLD. PLASTIC IN PANS ARE STARTING TO CRACK AND ALL RUBBER WAS STAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587330 ↗MalfunctionSep 9, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC IN THE TRAY IS FLAKING OFF. SPD WILL NO LONGER PROCESS THE TRAY. NO HARM TO PATIENT. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23006325 ↗MalfunctionJul 25, 2025Crack; Crack
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 22613398 ↗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 22378548 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 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
- Medical Action Industries 6010-1Medical Action Industries Inc. · 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.