Arthrex® AR-2600SBS-11Recalls & reported problems
Arthrex, Inc. · TKL SPDBRG IMP SYS W/ BC SWVLK & NDL · 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 00888867369665), received between Oct 10, 2024 and Oct 10, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2024Break; Break
ON 10/1/024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT ONE OF THE BLUE SWIVELOCK ANCHOR FROM AN AR-2600SBS-11 KNOTLESS SPEEDBRIDGE IMPLANT SYSTEM BROKE DURING INSERTION. THE FRAGMENTS WERE NOT REMOVED. THE CASE WAS COMPLETED USING THE REST OF THE KNOTLESS SPEEDBRIDGE KIT AND AN INDIVIDUAL ANCHOR. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED MORE THAN FIFTEEN MINUTES WITH ADDITIONAL ANESTHESIA. ADDITIONAL INFORMATION RECEIVED ON 10/8/2024: THE SURGEON USED A MALLET LIGHTLY TO IMPACT THE ANCHOR. AFTER THE ANCHOR BROKE, A SNAP WAS HEARD, AS IF THE SUTURES HAD BROKEN INSIDE THE EYELET. THE SUTURES WERE JAMMED IN THE SWIVELOCK INSERTER AND NO LONGER SLIDING. THE ANCHOR REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 20418327 ↗
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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