NA 2178-65-125Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL VIEW PLATE SIZE 2.5 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy M.B.T. Revision Tibial View Plate is a plastic sizing plate used to size the tibia during knee surgery. The 72 reports mostly describe the plate cracking, snapping in half or breaking into two pieces, often found during inspection of loaner kits or while trialing sizing; one injury was reported and no deaths. Most reports describe no effect on the patient. No recalls name this device, and reports dropped from 2 in the prior 12 months to none in the last 12 months.
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
- 72
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10603295096665), received between Jun 29, 2017 and Sep 5, 2025 — classified as 1 injury, 71 malfunctions.
The most frequently reported specific device problem is “Break” (58 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break58
- Crack14
- Scratched Material3
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient41
- No Information17
- No Clinical Signs, Symptoms or Conditions14
- No Code Available1
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025Crack; Crack
IT WAS REPORTED THAT THE INSTRUMENT WAS CRACKED. THE ISSUE WAS IDENTIFIED DURING LOAN KIT INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22975981 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED THAT WHILE TRIALING, THE INSTRUMENT BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22178827 ↗MalfunctionSep 20, 2024Crack; Crack
THE INSTRUMENT CONTAINS A CRACK. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273404 ↗MalfunctionAug 26, 2024Break; Break
THIS INSTRUMENT HAS CRACKED, DIVIDED INTO TWO PARTS.THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20063956 ↗MalfunctionJan 5, 2023Break; Break
IT WAS REPORTED THAT WHEN SURGEON WAS SIZING THE TIBIA THE PLASTIC TIBIAL TRIAL WAS CRACKED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16102288 ↗MalfunctionAug 1, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT PLATE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15141872 ↗MalfunctionMar 11, 2022Break; Break
INSTRUMENT BROKE BEFORE OPERATION BUT WASN'T REQUIRED FOR THIS PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13739072 ↗MalfunctionDec 20, 2021Break; Break
TIBIAL VIEW PLATE HAS SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13044099 ↗MalfunctionSep 29, 2021Break; Break
ALL VIEW PLATES HAVE SNAPPED IN HALF. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. CUSTOMER REFERENCE/PO/SERVICE --> (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12547197 ↗MalfunctionSep 14, 2021Break; Break
IT WAS REPORTED THAT THE MBT REV TIBIAL VIEW PLT SZ2.5 BROKE DURING TRIALING. ALL PIECES WERE RETRIEVED FROM PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12468152 ↗MalfunctionJul 20, 2021Crack; Crack
IT WAS REPORTED THAT THE SIZE 2.5 MBT REV TIBIAL VIEW PLATE IS CRACKED AND NEEDS TO BE REPLACED. NO PIECES WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12195541 ↗MalfunctionJun 23, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN UPON INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12051083 ↗MalfunctionJun 21, 2021Break; Break
VIEW PLATE HAS SNAPPED IN HALF. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12033612 ↗MalfunctionDec 15, 2020Break; Break
BOTH TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11007885 ↗MalfunctionOct 12, 2020Break; Break
MBT REV VIEW PLATE HAS SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10662815 ↗MalfunctionSep 24, 2020Crack; Crack
IT WAS REPORTED THAT THE VIEW PLATE IS CRACKED. THIS DID NOT OCCUR DURING THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10581993 ↗MalfunctionJul 22, 2020Crack; Crack
IT WAS REPORTED THAT AFTER THE CASE AND AFTER THE INSTRUMENTS WERE WASHED THEY NOTICED A CRACK IN THE SIZE 2.5 MBT TEMPLATE. NEED TO REPLACE AND DO NOT BREAK IN A CASE.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10311028 ↗MalfunctionJul 22, 2020Break; Break
SZ 2.5 PLASTIC VIEWPLATE BROKE INTRAOPERATIVELY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10308509 ↗MalfunctionJul 22, 2020Scratched Material; Scratched Material
MalfunctionFeb 5, 2020Crack; Scratched Material; Crack; Scratched Material
THE MBT REV TIBIAL VIEW PLT SZ2.5 WAS CRACKED IN THE MIDDLE SECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9672475 ↗MalfunctionJan 28, 2020Break; Break
RECEIVED FOLLOW-UP INFORMATION AD (B)(6) 2020 STATING THAT THE INSTRUMENT WAS BROKEN INTO 2 PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9640209 ↗MalfunctionJan 16, 2020Break; Break
ALL FOUR MBT TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9596034 ↗MalfunctionJan 2, 2020Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SZ 5, 3 AND 2.5 VIEW PLATES WERE CRACKED, CHIPPED. DAMAGED FOUND WHEN THEY RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9540617 ↗MalfunctionSep 26, 2019Break; Break
IT WAS REPORTED THAT THE TRIAL VIEWING PLATE BROKE IN HALF DURING SURGERY, UNSURE HOW IT HAPPENED IT WAS JUST NOTICED BROKEN AT THE END OF CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9123691 ↗MalfunctionSep 25, 2019Break; Crack; Break; Crack
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN INTO 2 PIECES AND ALL WERE RECOVERED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9117878 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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