FuseFix Hammertoe M13-S20113-SRecalls & reported problems
Tyber Medical, LLC · FuseFix Solid 10° Ø2.0mm x 13mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M695M13S20113S0), received between Jun 11, 2019 and Jun 11, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 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.
Most reported problems
Device problems
- Use of Device Problem2
Patient problems
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2019Use of Device Problem; Use of Device Problem
CUSTOMER REPORTED ON (B)(6) 2018 DURING A SURGICAL PROCEDURE, AS THE SURGEON WAS DRIVING THE IMPLANT IN THE PROXIMAL PHALANX, THE IMPLANT BROKE OFF. A PORTION OF THE IMPLANT WAS LEFT IN THE PATIENT. NO PATIENT HARM WAS REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8688814 ↗MalfunctionJun 11, 2019Use of Device Problem; Use of Device Problem
CUSTOMER REPORTED ON (B)(6) 2018 DURING A SURGICAL PROCEDURE, AS THE SURGEON WAS DRIVING THE IMPLANT IN THE PROXIMAL PHALANX, THE IMPLANT BROKE OFF. A PORTION OF THE IMPLANT WAS LEFT IN THE PATIENT. NO PATIENT HARM WAS REPORTED. PRODUCT WILL BE RETURNED FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8688598 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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