NA 2178-65-110Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL VIEW PLATE SIZE 1 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295096634), received between Aug 8, 2018 and Aug 3, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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.
Most reported problems
Device problems
- Break5
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2021Break; Break
IT WAS REPORTED THAT THE VIEW PLATE BROKE DURING POST CASE STERILIZATION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12268009 ↗MalfunctionDec 3, 2019Break; Break
IT WAS REPORTED THAT THE TRIAL IS BROKEN AT TOP. NEEDS TO BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9401453 ↗MalfunctionFeb 14, 2019Break; Break
IT WAS REPORTED THAT THE VIEW PLATE WAS BROKEN. DISCOVERED WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8339906 ↗MalfunctionFeb 8, 2019Break; Break
IT WAS REPORTED THAT THE VIEW PLATE WAS FOUND TO BE BROKEN WHEN SET WAS RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8321363 ↗MalfunctionAug 8, 2018Break; Break
IT WAS REPORTED THAT THE FOLLOWING PIECES WERE FOUND WHEN SETTING UP FOR A CASE. A 2 ATTUNE RP PS ARTIC SURF SZ7 (CIRCULAR SPRINGS ON THESE ARE DAMAGED), ZIMMER HUDSON TO HUDSON ADAPTOR, MBT REV TIBIAL VIEW PLATE SZ1 (BROKEN IN HALF), AND AN ATTUNE FEMORAL IMPACTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7761676 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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