FASTIN ETHIBOND 222140Recalls & reported problems
Depuy Mitek, LLC · FASTIN ANCHOR Size 2 (5 metric) green ETHIBOND braided polyester suture, 26 Inches (66cm), Anchor 4.0mm Diameter x 9.7mm long. · 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 10886705007509), received between Apr 2, 2019 and Oct 16, 2024 — 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
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2024Break; Break
IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE FASTIN 4.0MM #2 ETH EA DEVICE SUTURE WAS BROKEN. DURING THE SURGERY, WHEN TIGHTENED THE SUTURE BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20462906 ↗MalfunctionApr 2, 2019Failure to Advance; Failure to Advance
IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING AN UNKNOWN PROCEDURE, THE DOCTOR COULD NOT GET ANY TORQUE WHEN ATTEMPTING TO INSERT THE 4MM FASTIN ANCHOR INTO THE PATIENT. THE CASE WAS COMPLETED WITH A DIFFERENT TYPE OF IMPLANT WITH NO PATIENT HARM OR DELAY. THE IMPLANT WAS DISCARDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8475968 ↗
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- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 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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