Arthrex® AR-1665KBCSLRecalls & reported problems
Arthrex, Inc. · LNT Implant System, 4.75 BC KL Swivelock · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867367289), received between Oct 20, 2023 and Jan 9, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Break; Break
ON 12/12/2024, A MAUDE REVIEW NOTIFICATION WAS RECEIVED VIA EMAIL THAT THE METAL TIP OF THE LOOP 'N' TACK SWIFTSTITCH SUTURE PASSER FROM AN AR-1665KBCSL LNT IMPLANT SYSTEM BROKE AND WAS DIRECTED IN THE INFERIOR POUCH. A SEPARATE INFERIOR POUCH AXILLA HAD TO BE ESTABLISHED TO REMOVE THE FOREIGN METAL BODY. THIS WAS DISCOVERED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 21114477 ↗MalfunctionOct 23, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE SWIVELOCK FROM AN AR-1665KBCSL LOOP N TACK IMPLANT SYSTEM TIP BROKE DURING INSERTION. THE SURGEON REMOVED ALL THE BROKEN FRAGMENTS AND USED AN INDEPENDENT SWIVELOCK TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 17985864 ↗MalfunctionOct 20, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE SWIVELOCK FROM AN AR-1665KBCSL LOOP N TACK IMPLANT SYSTEM TIP BROKE DURING INSERTION. THE SURGEON REMOVED ALL THE BROKEN FRAGMENTS AND USED AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 17978228 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- 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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