Arthrex® AR-1662BCC-8-1Recalls & reported problems
Arthrex, Inc. · SWVLK TENO BIO-COMP 8X 19.1MM · 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 00888867283596), received between Aug 3, 2021 and Aug 3, 2021 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2021Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE PEEK EYELET OF THE DEVICE BROKE DURING IMPLANTATION. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE TENDON COULD NO LONGER BE BURIED IN THE BONE TUNNEL, SO THE SURGEON HAD TO MAKE A COMPLETE TUNNEL INSTEAD OF A PARTIAL ONE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-1662BC-7-1). IT WAS NOT NECESSARY TO DO A SECOND SURGERY.
Patient problems: Insufficient Information
MAUDE report 12268692 ↗
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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