NA 241.622Recalls & reported problems
Synthes GmbH · LOCKING CALCANEAL PLATE SHORT-RIGHT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982167392), received between Aug 3, 2023 and Aug 3, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Discomfort1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT# 4, DIABETES MELLITUS- YES, INDEX SURGERY. THERE WAS POST- OPERATIVE COMPLICATION BECAUSE THE PATIENT HAD PAIN IN THE JOINT. COMMENTS/NOTES: PATIENT DID NOT RETURN TO WORK UNTIL FOLLOWING ANKLE ARHTROSCOPY SECONDARY TO PERSISTENT ANKLE PAIN/DISCOMFORT FOLLOWING SURGERY. ANKLE ARHTROSCOPY YIELDED SOME BONY DEBRIS-DEBRIDED WITH SUCCESS. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO INTRA-OP COMPLICATIONS WERE REPORTED THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE SHORT-RIGHT. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).
Patient problems: Discomfort; Pain
MAUDE report 17454642 ↗
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE devices
- LOCK SCREW SQUARE DRIVE 131827118Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- LOCK SCREW SQUARE DRIVE 131827120Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- IJS IJS-E Base Plate AssemblySkeletal Dynamics L.L.C. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE28 reports
- NA 390.008Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE21 reports
- NA 294.56Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 390.003Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 394.85Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1Orthofix Srl · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite6 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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