TruShot Y18TN-FARecalls & reported problems
Conmed Corporation · TruShot™ FA with Y-Knot® 1.8 mm All-Suture Anchor with two #2 (5 metric) Hi-Fi® Sutures with Needles, for Foot and Ankle · 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 20653405988394), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Break; Break
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT Y18TN-FA, TRUSHOT FA W/ALL-SUTURE ANCHOR W/HI-FI SUTURES W/NEEDLES WAS BEING USED ON (B)(6) 2024 DURING A BICEPS TENODESIS PROCEDURE WHEN IT WAS REPORTED ¿METAL TYNE BREAK OFF.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THE FRAGMENT WAS BURIED AND LEFT IN THE HUMERAL BONE. IT WAS CONFIRMED BY X-RAY TO BE BURIED IN BONE. REMOVING WOULD HAVE CAUSED MORE DAMAGE.¿. THE PROCEDURE WAS COMPLETED WITH A 15-MINUTE DELAY AND THERE WAS NO REPORT IF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN BODY.
Patient problems: Foreign Body In Patient
MAUDE report 20517239 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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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