NA 2178-65-150Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL VIEW PLATE SIZE 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 an orthopedic manual surgical instrument. The 41 reports mostly describe the plate or related instruments breaking or cracking, sometimes with broken pieces recovered. There are no deaths and no injuries. 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
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295096696), received between Jun 29, 2017 and Feb 11, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Break” (32 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
- Break32
- Crack10
- Material Deformation1
- No Apparent Adverse Event1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient28
- No Information8
- No Clinical Signs, Symptoms or Conditions5
- Not Applicable1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316843 ↗MalfunctionMay 20, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SHIM TEMPLATE 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 AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355769 ↗MalfunctionJan 4, 2024Crack; Crack
THIS INSTRUMENT IS COMPOSED OF 1 PART. THERE WAS A CRACK ON THE MBT REV TIBIAL TRIAL. 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 AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18446275 ↗MalfunctionFeb 16, 2022Crack; Crack
IT WAS REPORTED THAT RECEIVED DAMAGED INSTRUMENT BY SPD TECH ON (B)(6) 2022. THE TIBIAL SIZER WAS CRACKED AND LEFT OUT OF THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13540978 ↗MalfunctionDec 10, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC TIP OF THE TORQUE WRENCH BROKE OFF PREVENTING THEM FROM BEING ABLE TO TIGHTEN THE ADAPTOR BOLT. ALL PIECES WERE RETRIEVED FROM THE PATIENT, HOWEVER, THE PLASTIC PIECE WAS THROWN AWAY AND WILL NOT BE BEING RETURNED. THE WRENCH PORTION WILL BE BEING RETURNED. IT WAS ALSO REPORTED THAT WHILE SIZING THE TIBIA, THE VIEW PLATE BROKE IN HALF. BOTH PIECES WERE RECOVERED FROM PT AND ARE BEING RETURNED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10984740 ↗MalfunctionJul 22, 2020Scratched Material; Scratched Material
MalfunctionApr 2, 2020Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN SPD AND WORN OUT/STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9917084 ↗MalfunctionJan 16, 2020Break; Break
ALL FOUR MBT TIBIAL VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9596050 ↗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 9540620 ↗MalfunctionAug 9, 2019Break; Break
PIECE OF VIEW PLATE BROKE OFF DURING SURGERY, RESULTED IN NO DELAY. ITEM DID BREAK INTO 2 PIECES, BOTH RETRIEVED. PART THAT BROKE WAS AROUND CENTRAL HOLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8880177 ↗MalfunctionJul 30, 2019Break; Break
IT WAS REPORTED THAT WE LOST BUSINESS A LOT OF BUSINESS HERE IN TOWN. ALL INSTRUMENTS HAVE BEEN PULLED TO RE-ALLOCATE WITHIN OUR TERRITORY. BROKEN INSTRUMENTS WERE IN DESIGNATED BOX AT FACILITY LABELED AS "BROKEN" OR WERE FOUND IN STERILE WRAPPED SETS THAT WERE RETURNED TO THE OFFICE. NO PATIENT WAS AFFECTED. NO SURGERY WAS AFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8841170 ↗MalfunctionFeb 22, 2019Crack; Crack
MalfunctionFeb 18, 2019Crack; Crack
IT WAS REPORTED THAT WHILE TRIALING, THE KNEE WAS PUT THROUGH RANGE OF MOTION AND THE TRIAL WAS CRACKED IN HALF. THE TRIAL WAS THEN SIZED UP TO A 6 VIEW PLATE WHICH WAS ALSO CRACKED DURING TRIALING. NO TIME WAS ADDED TO THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8347314 ↗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 8184768 ↗MalfunctionDec 7, 2018Break; Break
MalfunctionNov 29, 2018Break; Break
BOTH VIEW PLATES HAVE SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8118431 ↗MalfunctionOct 23, 2018Crack; Crack
IT WAS REPORTED THAT THE SIZING PLATE CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7996451 ↗MalfunctionAug 13, 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 7776203 ↗MalfunctionJun 11, 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 7588969 ↗MalfunctionJun 8, 2018Break; Break
IT WAS REPORTED THAT UPON PLACING THE TIBIAL SIZING VIEW PLATE ON THE TIBIA AND WHEN IT WAS REMOVED, IT WAS IN TWO PIECES. WHEN THE SCRUB TECH WAS GOING TO LIFT THE UPPER TRAY OUT OF THE PAN TO GET TO THE BOTTOM, IT BROKE IN HALF. ALL PIECES ARE BEING RETURNED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7582478 ↗MalfunctionJun 8, 2018Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN IN SPD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7582039 ↗MalfunctionJun 7, 2018Break; Break
VIEW PLATES HAVE ALL 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 7577433 ↗MalfunctionMay 25, 2018Break; Break
VIEW PLATE HAS SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7544693 ↗MalfunctionMay 24, 2018Break; Break
IT WAS REPORTED THAT TIBIAL SIZING CLEAR DISC SNAPPED IN HALF. SURGERY DELAY OF 5 MINS.
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 7541376 ↗MalfunctionMay 15, 2018Break; Break
VIEW PLATE HAS SNAPPED IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7514363 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- 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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