EasyFuse™ FFS4MTPSRecalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
All models of EasyFuse (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889797103534), received between Apr 24, 2023 and Apr 24, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K203832); they may or may not involve this specific model.
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
- Break1
- Fracture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THERE WAS A REVISION SURGERY. THE MTP STAPLE WAS IMPLANTED BUT NEEDED TO BE REPOSITIONED. WHEN TAKEN OUT AND RELOADED ON TO IMPLANT CARTRIDGE, THE CARTRIDGE SNAPPED AND BECAME UNABLE TO USE.
Patient problems: Insufficient Information
MAUDE report 16800826 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K203832. One submission often covers many models, so check the product and lot details in each record.
- Z-0853-2022 · Mar 10, 2022 · TerminatedEasyFuse Dynamic Compression System Instrument Pack
Other Staple, fixation, bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 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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