Arthrex® AR-1920BFRecalls & reported problems
Arthrex, Inc. · BIOCRKSCRW SUTR ANCH 5MM W/2 #2 FW · 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 00888867022706), received between Jul 25, 2017 and Jul 25, 2017 — 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.
Most reported problems
Device problems
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2017Break
IT WAS ORIGINALLY REPORTED VIA MEDWATCH REPORT (B)(4) THAT A BIOCOMPOSITE ANCHOR, AR-1920BF, BROKE AT THE RUN OUT OF INSERTION. MEDWATCH REPORT STATED THAT THE DEVICE WAS ACCURATELY USED BY SURGEON. PER MEDWATCH REPORT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT THE PROCEDURE WAS A KIDNER GASTROC RECESSION WITH EVANS OSTEOTOMY. THE ANCHOR BROKE IN THE MIDDLE OF THE PROCEDURE AND A PORTION OF THE ANCHOR REMAINS IN THE PATIENT. THE HEAD OF THE ANCHOR STAYED IN THE BONE, BUT THE SUTURE BROKE AWAY SO THE TISSUE WAS UNABLE TO BE TIED DOWN. THE CASE WAS COMPLETED USING ANOTHER ANCHOR TO TIE THE TISSUE DOWN. THE SURGEON'S TECHNIQUE DID NOT CHANGE DUE TO THE SUTURE BREAKING AWAY FROM THE ANCHOR.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6739477 ↗
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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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