MITEK TIGHT-N 208882Recalls & reported problems
Medos International Sàrl · MITEK TIGHT-N Tendon Docking Anchor PEEK Anchor MEDIUM 7.0mm · Class 2 · Implant
Data updated Oct 18, 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 10886705032655), received between Aug 26, 2025 and Aug 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE TIGHT-N TENDON ANCHOR, 7.0MM DEVICE WAS IMPLANTED INTO THE TUNNEL, EVERYTHING LOOKED INTACT, BUT WHEN THE LASER LINE WAS FLUSHED IT APPEARED THAT THE WHITE SEATBELT SUTURE SLIPPED UP AND THE TENDON WAS NOT DUNKED INTO THE TUNNEL WITH THE ANCHOR. USING A PROBE TO HELP VISUALIZE, IT WAS OBSERVED THE KNOT STACK FROM THE TIP OF THE ANCHOR APPEARED, AND THE IMPLANT WAS STILL IN THE TUNNEL. IT WAS REPORTED THAT THE SURGEON THEN USED THE WHITE STITCH AND STAY-STITCH TO PASS THROUGH THE TENDON AND ATTACHED IT TO THE ANCHOR. IT WAS REPORTED THAT THERE WAS A 20-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895313 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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