Snap-Off Screw System SK21Recalls & reported problems
Treace Medical Concepts, Inc. · 2.0mm Snap-Off Screw System · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00853114006143), received between Jun 21, 2023 and Jun 2, 2026 — classified as 7 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
Patient problems
- Skin Inflammation/ Irritation4
- Pain2
- Discomfort1
- Nonunion/Delayed-union Bone Fracture1
- Swelling/ Edema1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, TWO SNAP OFF SCREWS WERE REMOVED ON (B)(6) 2026 DUE TO SWELLING AND IRRITATION FROM SCREW TIP PROMINENCE. THE PATIENT'S BONES WERE COMPLETELY FUSED/HEALED. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 25361500 ↗InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO HARDWARE IRRITATION. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 21108652 ↗InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2021, A SNAP-OFF SCREW WAS REMOVED ON (B)(6) 2024 DUE TO PAIN AND IRRITATION. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain; Skin Inflammation/ Irritation
MAUDE report 20071488 ↗InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PROMINENT HARDWARE THAT BOTHERED THE PATIENT WHEN WEARING SHOES. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Discomfort
MAUDE report 19630668 ↗InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2022, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO IRRITATION FROM THE MEDIAL PLATE. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 19222023 ↗InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2022, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO PAIN. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain
MAUDE report 18148699 ↗InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2022, A SCREW WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO NONUNION. THE PATIENT WAS REVISED WITH A NEW TMC SCREW. THERE WAS NO OTHER REPORT OF ANY PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 17171937 ↗
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 STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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