Arthrex® AR-1927BCNF-45Recalls & reported problems
Arthrex, Inc. · 4.5 BIOCOMPOSITE FT WITH NEEDLES · Class 2 · Implant
Data updated Oct 16, 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 00888867096875), received between Mar 1, 2021 and Mar 1, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2021Break
IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE AR-1927BCNF-45 (LOT: 11576124) BROKE WHEN IT WAS ABOUT HALFWAY INSERTED AND COULD NOT BE RETRIEVED. AN ARTHREX SALES REPRESENTATIVE WAS NOT PRESENT DURING THE PROCEDURE. THE SURGEON INFORMED THE REP THAT THEY WERE ABLE TO ALTER THEIR TECHNIQUE AND COMPLETE THE CASE AS SCHEDULED.
Patient problems: Insufficient Information
MAUDE report 11393347 ↗MalfunctionMar 1, 2021Break
IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE AR-1927BCNF-45 (LOT: 11576124) BROKE WHEN IT WAS ABOUT HALFWAY INSERTED AND COULD NOT BE RETRIEVED. AN ARTHREX SALES REPRESENTATIVE WAS NOT PRESENT DURING THE PROCEDURE. THE SURGEON INFORMED THE REP THAT THEY WERE ABLE TO ALTER THEIR TECHNIQUE AND COMPLETE THE CASE AS SCHEDULED.
Patient problems: Insufficient Information
MAUDE report 11393330 ↗
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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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