NA 212029Recalls & reported problems
Depuy Mitek, LLC · Knotless Suture Anchor (Arthroscopic) Size 1 green ETHIBOND braided polyester suture Anchor Loop, Size 2/0 white ETHIBOND suture Utility Loop. · Class 2 · Implant
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 10886705001781), received between Aug 16, 2018 and Aug 16, 2018 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2018Break; Break
THE SALES REP REPORTED THAT THE FORK AT THE PROXIMAL END OF THE ANCHOR CUT THE SUTURE WHEN IT WAS BEING INSERTED. WHEN THE SURGEON TRIED TO REMOVE THE ANCHOR TO FIX THE SUTURE THE ANCHOR BROKE AND BECAME LODGED IN THE JOINT SPACE. THE SURGEON REMOVED THE ANCHOR WITH SUTURE GRASPERS AND COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE. THE SALES REP REPORTED THERE WERE NO PATIENT CONSEQUENCES OR TIME DELAY. THE SURGEON COMPLETED REMOVED THE FIRST ANCHOR AND USED THE SAME BONE HOLE FOR THE 2ND ANCHOR. THE SALES REP REPORTED THAT PATIENT WAS A MALE WITH GREAT BONE QUALITY. NO FURTHER INFORMATION WAS GIVEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7790760 ↗
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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