NA 2178-65-140Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL VIEW PLATE SIZE 4 · 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 trial plate used to check fit during knee replacement surgery. The 64 reports mostly describe the plate snapping in half, cracking, or wearing out — many noticed when technicians inspected loaner sets rather than during surgery — with no deaths and no injuries. There are no recalls naming 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
- 64
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10603295096689), received between Jun 29, 2017 and Sep 4, 2025 — classified as 64 malfunctions.
The most frequently reported specific device problem is “Break” (55 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
- Break55
- Crack8
- Naturally Worn2
- Dull, Blunt1
- Material Deformation1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient40
- No Information15
- No Clinical Signs, Symptoms or Conditions8
- Not Applicable1
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN IT WAS IDENTIFIED THAT THE MBT REV TIBIAL VIEW PLT SZ4 HAS BROKEN IN HALF. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. 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 22965909 ↗MalfunctionApr 25, 2023Break; Break
IT WAS REPORTED THAT TRIAL IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806705 ↗MalfunctionAug 1, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT PLATE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15141943 ↗MalfunctionJun 17, 2022Break; Break
IT WAS REPORTED THAT THE TIBIAL SIZER WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734643 ↗MalfunctionMay 12, 2022Break; Break
TIBIAL VIEW PLATE HAS SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14368197 ↗MalfunctionApr 29, 2022Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE TABS ON 14X75 PILOT SHAFT WAS BROKE. ALL PIECES WERE RETRIEVED. MBT SIZE 4 CLEAR TRIAL BROKE W/WEAR. NO PIECES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14251770 ↗MalfunctionFeb 11, 2021Break; Break
BOTH TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11313311 ↗MalfunctionDec 15, 2020Break; Break
BOTH TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11007863 ↗MalfunctionAug 6, 2020Break; Break
IT WAS REPORTED THAT THE WRENCH IS ROUNDED OFF AND WAS SLIPPING WHILE TIGHTENING THE STEMMED IMPLANT. THE SZ 4 VIEW PLATE BROKE DURING THE SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10374330 ↗MalfunctionJan 16, 2020Break; Break
ALL FOUR MBT TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9596032 ↗MalfunctionOct 18, 2019Break; Break
IT WAS REPORTED THAT THE PLATE WAS BROKEN DURING CASE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9209060 ↗MalfunctionAug 12, 2019Break; Break
IT WAS REPORTED THAT THE PIECE WAS BROKEN IN TRAY BEFORE CASE SIZE4 CLEAR PIECE TIBIA TRIAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8885549 ↗MalfunctionAug 6, 2019Break; Break
BOTH TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8864677 ↗MalfunctionJul 9, 2019Break; Break
SIZE 4 MBT REVISION SIZING GUIDE BROKE INTRAOPERATIVELY. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8770411 ↗MalfunctionJul 9, 2019Break; Naturally Worn; Break; Naturally Worn
ORTHO TECH REPORTED THE INSTRUMENT AS BROKEN FOLLOWING DECONTAMINATION FOLLOWING A CASE. REPLACEMENT INSTRUMENT REQUIRED FOR LTC KIT. IF OTHER, DESCRIBE, UNSURE IF BREAKAGE OCCURRED INTRA-OP OR POST-OP DUE TO GENERAL WEAR AND TEAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8770405 ↗MalfunctionJun 5, 2019Break; Break
DURING INSPECTION, IT WAS NOTICED THAT PRODUCT WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8670428 ↗MalfunctionJun 5, 2019Break; Break
DURING INSPECTION, IT WAS NOTICED THAT PRODUCT WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8670415 ↗MalfunctionMay 31, 2019Break; Break
IT WAS REPORTED THAT THE MBT REV TIBIAL VIEW PLT SZ4 CLEAR PLASTIC SIZER WAS SPLIT IN TWO. EVERYTHING WAS RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8659602 ↗MalfunctionApr 26, 2019Break; Break
SZ4 TIBIAL 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 8556108 ↗MalfunctionMar 22, 2019Crack; Crack
SURGEON WAS USING THE VIEW PLATE TO REAM THROUGH TO MAKE SURE HE WAS CENTERED. REAMED UP AND THEN DIDN'T REMOVE IT BEFORE THE PROXIMAL REAMER AND IT CRACKED AND BROKE THE VIEW PLATE. ALSO, SPD NOTICED WHEN THEY WERE PUTTING THE SET BACK TOGETHER THAT THE OTHER PLATE WAS CRACKED. UNSURE OF WHEN THAT HAPPENED WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> REMOVED BROKEN 2 PIECES AND MOVED ON, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> YES, IF NO, EXPLAIN --> PERFECT BREAK IN TWO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, ACTIVITY LEVEL --> UNKNOWN, (B)(4) DEVICE PROPERTY OF -->HOSPITAL, DEVICE IN POSSESSION OF -->(B)(6), (B)(4). DEVICE PROPERTY OF -->HOSPITAL, DEVICE IN POSSESSION OF -->(B)(4) 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
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8444833 ↗MalfunctionFeb 22, 2019Crack; Crack
IT WAS REPORTED THAT VIEW PLATES WERE CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8361294 ↗MalfunctionFeb 22, 2019Crack; Crack
MalfunctionFeb 20, 2019Break
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. OFFICE SETS, DID NOT EFFECT SURGERY NOR PATIENT. (B)(6) 2019 EXAMINATION OF THE RETURNED DEVICE REVEALED DEVICE BREAKAGE. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8353445 ↗MalfunctionDec 20, 2018Crack; Crack
IT WAS REPORTED THAT THE TRIALS ARE CRACKED. HUDSON WILL NOT LOCK ONTO REAMERS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8184795 ↗MalfunctionNov 29, 2018Break; Break
BOTH VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8118433 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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