Arthrex® AR-1662PSL-8Recalls & reported problems
Arthrex, Inc. · SWVLK PEEK TENO 8MM W/FORK EYELET · 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 00888867020658), received between Jan 3, 2025 and Feb 12, 2026 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
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.
MalfunctionFeb 12, 2026Break
ON 26-JAN-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1662PSL-8 SWIVELOCK TENODESIS SUTURE ANCHOR BROKE AT THE TIP WHEN IT WAS LIGHTLY TOUCHED TO THE BONE SURFACE DURING INSERTION. NO FRAGMENTS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-1662PSL-8 SWIVELOCK TENODESIS SUTURE ANCHOR. THERE WAS NO SIGNIFICANT DELAY; NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24324778 ↗MalfunctionJan 3, 2025Break; Break
ON 12/9/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1662PSL-8 SWIVELOCK TENODESIS, PEEK GOT DAMAGED; ALTHOUGH, IT DID NOT HIT ANYTHING DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024. THE CASE WAS COMPLETED USING ANOTHER AR-1662PSL-8 SWIVELOCK TENODESIS, PEEK. ADDITIONAL INFORMATION RECEIVED ON 12/17/2024: THIS WAS DISCOVERED DURING A BICEPS TENODESIS. THE EYELET OF THE SWIVELOCK GOT DAMAGED DURING INSERTION AND ALL THE BROKEN FRAGMENTS WERE REMOVED ALONG WITH THE ANCHOR. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067828 ↗
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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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