TRI-LOCK 2012-06-300Recalls & reported problems
Depuy (Ireland) · TRI-LOCK BPS W/GRIPTION CASE COMPLETE · Class 1
Quick summary
This DePuy Tri-Lock surgical instrument tray and broach pan set is used to hold and organize orthopedic surgical tools. The 27 reports mostly describe trays and cases peeling apart, cracking, chipping, fading and delaminating after years of repeated cleaning and sterilization. No deaths or injuries were reported, and 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295082323), received between Oct 9, 2017 and Apr 1, 2024 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (11 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/Delaminated11
- Break9
- Material Discolored9
- Delamination5
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
Patient problems
- No Consequences Or Impact To Patient22
- No Clinical Signs, Symptoms or Conditions5
- No Information5
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE METAL AND PLASTIC IS BREAKING AND CHIPPING OFF OLD TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011464 ↗MalfunctionApr 1, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE METAL AND PLASTIC IS BREAKING AND CHIPPING OFF OLD TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011410 ↗MalfunctionAug 10, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS WERE PEELING AND FALLING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12302369 ↗MalfunctionAug 10, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS WERE PEELING AND FALLING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12302368 ↗MalfunctionJun 1, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE T-HANDLE HAS A CRACK IN IT AND NEEDS REPLACED. THIS DID NOT OCCUR DURING THE CASE, BUT DISCOVERED BEFOREHAND. ALSO, THE TRILOCK GRAPHIC CASE HAS PLASTIC PEELING OFF AND NEEDS REPLACED PER SPD GUIDELINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11916441 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSING'S.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267854 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSINGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267847 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSINGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267843 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSING'S.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267840 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSINGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267824 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSINGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267821 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSING'S.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267820 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSINGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267811 ↗MalfunctionJul 13, 2020Break; Material Discolored; Break; Material Discolored
TRILOCK BROACH PAN HAVE FADED AND HAVE STARTED TO CHIP AFTER BEING IN ROTATION FOR APPROX. 10 YEARS AND THOUSANDS OF CASE REPROCESSINGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267810 ↗MalfunctionMay 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
CUSTOMER HAS BEEN USING THE TRILOCK TRAYS FOR ABOUT 3 MONTHS. NOW THIS ISSUE IS OCCURING: THE TRAYS HAVE BEEN WASHED ABOUT 7 TIMES UP TO NOW AND AFTER THE STERILIZATION THERE IS A KIND OF "CHALK DUST" ON THE TRAYS. THIS HAPPENS ONLY WHEN WASHING THE TRILOCK TRAYS, ALL OTHER TRAYS BEHAVE NORMALLY. THE CAUSE IS UNKNOWN BUT THE "CHALK-LIKE LAYER" IS LOCATED ON THE INSIDE AND OUTSIDE OF THE ENTIRE TRAY. THE FEAR IS THAT PARTICLES OF THIS LAYER ARE ON THE INSTRUMENTS AND CAN COME IN CONTACT WITH THE PATIENT. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8592234 ↗MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
MalfunctionDec 26, 2018Peeled/Delaminated; Peeled/Delaminated
MalfunctionAug 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE BLACK COATING PART OF THE STERILIZED CASE PEDESTAL PART WAS PEELED OFF AND THE METAL PART WAS EXPOSED DURING THE PREPARATION OF THE SURGERY ON (B)(6) 2018. THE HOSPITAL STAFF TRANSFERRED THE CONTENTS OF THE REPORTED PRODUCT TO THE ALTERNATIVE CASE TO STERILIZE. THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7814426 ↗MalfunctionOct 9, 2017Delamination; Delamination
IT WAS REPORTED THAT THE RUBBER BROACH HOLDERS ARE STARTING TO LOSE PARTS. SEPTEMBER 15, 2017 - EVALUATION OF THE RETURNED CASES FOUND SOME OF THE BRACKETS ARE DELAMINATING. (B)(6).
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6928172 ↗MalfunctionOct 9, 2017Delamination; Delamination
IT WAS REPORTED THAT THE RUBBER BROACH HOLDERS ARE STARTING TO LOSE PARTS. SEPTEMBER 15, 2017 - EVALUATION OF THE RETURNED CASES FOUND SOME OF THE BRACKETS ARE DELAMINATING. (B)(6).
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6928163 ↗MalfunctionOct 9, 2017Delamination; Delamination
IT WAS REPORTED THAT THE RUBBER BROACH HOLDERS ARE STARTING TO LOSE PARTS. SEPTEMBER 15, 2017 - EVALUATION OF THE RETURNED CASES FOUND SOME OF THE BRACKETS ARE DELAMINATING. (B)(6).
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6928154 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
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- 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.