NA 2178-65-120Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL VIEW PLATE SIZE 2 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy M.B.T. Revision Tibial View Plate is a plastic sizing trial plate used to check bone fit during knee replacement surgery. The 51 reports mostly describe the plate snapping or cracking in half, sometimes while sizing the tibia or during handling or inspection. No deaths and 1 injury were reported, and most cases had no effect on the patient. 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
- 51
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295096658), received between Jun 29, 2017 and Aug 26, 2024 — classified as 1 injury, 50 malfunctions.
The most frequently reported specific device problem is “Break” (45 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
- Break45
- Crack8
- Fracture1
Patient problems
- No Consequences Or Impact To Patient23
- No Information19
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2024Crack; Crack
IT WAS REPORTED THAT THE INSTRUMENT IS CRACKED. 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 20063804 ↗MalfunctionJun 15, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE WHEN TRAILING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136561 ↗MalfunctionAug 2, 2022Break; Break
IT WAS REPORTED THAT THE BASE PLATE TRIAL BROKE INTO TWO PIECES. IT WAS DISPOSED OF BY STAFF AFTER THE CASE. THE SZ 7 SHIM WOULDN¿T ATTACH ONTO THE SPACER BLOCK. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15149409 ↗MalfunctionFeb 1, 2022Break; Crack; Break; Crack
VIEW PLATE HAS SNAPPED IN HALF AND HAS SMALL CRACKS AROUND OUTER EDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13419064 ↗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 STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12547160 ↗MalfunctionMar 24, 2021Break; Break
TIBIAL VIEW PLATE CRACKED IN HALF WHILE SIZING THE TIBIA. NO FRAGMENTS GENERATED, NO TIME ADDED TO CASE. BROKE FROM A/P AND SPLIT RIGHT NOW THE MIDDLE IN 2 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11563020 ↗MalfunctionFeb 11, 2021Break; Break
BOTH TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11313306 ↗MalfunctionFeb 1, 2021Break; Break
IT WAS REPORTED THAT THE PLASTIC MBT TIBIAL TRIAL BROKE IN HALF AFTER REMOVING FROM ON TOP OF BROACH IN THE TIBIA. NO DELAY IN SURGERY, ALL PIECES WERE RECOVERED. BROKE INTO TWO PIECES, JUST NEEDS REPLACED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11263351 ↗MalfunctionDec 1, 2020Break; Break
IT WAS THAT THE THREE INSTRUMENTS WERE BROKEN DURING THE SURGERY. THE MODIFIED HUDSON ADAPTOR WOULD NOT LOCK THE REAMER IN PLACE. THE REAMER STEM WAS ROUNDED OFF, AND THE TIBIAL VIEW PLATE WAS BROKEN IN 2 PIECES. ALL PIECES WERE RECOVERED. IT DID NOT EXTEND THE TIME OF THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10931051 ↗MalfunctionJan 16, 2020Break; Break
ALL FOUR MBT TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9596051 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE PART# D217865120 SIZE 2 WAS FOUND BROKEN WHEN TRAYS WERE BEING ASSEMBLED IN SPD. THE INSTRUMENT WAS NOT USED DURING THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9504189 ↗MalfunctionNov 8, 2019Crack; Crack
IT WAS REPORTED THAT THE SZ 2 VIEW PLATE WAS CRACKED, SIGMA SP*2 POLY TIB COMP IMPACTOR OLD AND WORN, ATTUNE CONV RP PS TB TRL SZ9 - DEEP SCRATCHES, DISCOLORED, ARTIC/EZE TR BALL GRVD 32+1 - DEEP SCRATCHES, WORN SURFACE. ALL ARE FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9298059 ↗MalfunctionSep 13, 2019Break; Break
IT WAS REPORTED THAT THE PLATE WAS BROKEN WHILE REMOVING FROM BROACH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9034410 ↗MalfunctionJul 24, 2019Break; Break
BOTH TIBIAL 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8821732 ↗MalfunctionApr 5, 2019Break; Crack; Break; Crack
IT WAS REPORTED THAT THE MBT REV TIBIAL VIEW PLT SZ2 WAS CRACKED IN HALF AT THE TOP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8486510 ↗MalfunctionFeb 22, 2019Crack; Crack
IT WAS REPORTED THAT VIEW PLATES WERE CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8361300 ↗MalfunctionJan 15, 2019Crack; Crack
IT WAS REPORTED THAT THE INSTRUMENT TRIALS WAS CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8248352 ↗MalfunctionJan 7, 2019Break; Break
IT WAS REPORTED THAT THE VIEW PLATE BROKE INTO TWO PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8223499 ↗MalfunctionOct 8, 2018Break; Break
IT WAS REPORTED THAT THE SIZE 2 TIBIAL VIEW PLATE WAS BROKEN IN HALF UPON INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7944765 ↗MalfunctionJun 11, 2018Break; Break
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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7586434 ↗MalfunctionMay 30, 2018Break; Break
VIEW PLATE HAS 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7552849 ↗MalfunctionMay 15, 2018Break; Break
VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7514302 ↗MalfunctionMay 15, 2018Break; Break
VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7514290 ↗MalfunctionMay 14, 2018Break; Break
IT WAS REPORTED THAT THE MBT REVISION TIBIAL PLATE SIZE 2X2 WERE BOTH BROKEN DURING SURGERY AND NEED TO BE REPLACED. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7511035 ↗MalfunctionMay 14, 2018Break; Break
IT WAS REPORTED THAT THE MBT REVISION TIBIAL PLATE SIZE 2X2 WERE BOTH BROKEN DURING SURGERY AND NEED TO BE REPLACED. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7510960 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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