MITEK TIGHT-N 208881Recalls & reported problems
Medos International Sàrl · MITEK TIGHT-N Tendon Docking Anchor PEEK Anchor SMALL 5.5mm · Class 2 · Implant
Data updated Oct 18, 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 10886705032600), received between Jan 25, 2023 and May 5, 2025 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE STAY SUTURE IN THE ANCHOR OF THE TIGHT-N TENDON ANCHOR, 5.5MM DEVICE WAS FOUND TO BE TANGLED. THE SURGEON MANAGED TO UNTANGLE THE STAY SUTURE. THE PROCEDURE WAS SLIGHTLY DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. IT WAS REPORTED THAT THE SAME DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962457 ↗MalfunctionJan 25, 2023Break; Break
IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A BICEPS TENODESIS, THE TRUEFIX 5.5MM ANCHOR SYSTEM SPLIT IN HALF WHEN BEING IMPLANTED. THE ANCHOR WAS ABOUT A QUARTER OF THE WAY IN WHEN IT BROKE. IT WAS USED ON THE PATIENT, BUT NO HARM TO THE PATIENT. PERFORMED THE BICEPS TENODESIS WITHOUT TIGHT-N AND USED SPEEDTRAP INSTEAD. NO DELAY REPORTED, THE DEVICE IS AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16240666 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page