Arthrex® AR-2600SBS-6Recalls & reported problems
Arthrex, Inc. · SPEEDBRG IMPL SYS W/ PEEK SWVLK · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867160224), received between Nov 22, 2023 and Apr 24, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 6/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2600SBS-6 SPEEDBRIDGE IMPLANT SYSTEM WITH PEEK SWIVELOCK GREEN TIP OF THE HANDLE SPLIT DURING INSERTION. SURGEON REMOVED IT FROM INSIDE THE PATIENT AND NOTICED THE ANCHOR WAS NOT ASSEMBLED PROPERLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 19173533 ↗InjuryNov 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2023, IT WAS REPORTED BY AN INFECTIOUS DISEASE FACILITY REPRESENTATIVE VIA PHONE THAT A PATIENT WHO UNDERWENT SURGERY ON 3/1/2023 IS NOW EXPERIENCING AN INFECTION. AN AR-1665PSL PEEK LOOP 'N' TACK¿ TENODESIS IMPLANT SYSTEM AND AN AR-2600SBS-6 SPEEDBRIDGE IMPLANT SYSTEM WITH PEEK SWIVELOCK ANCHORS WERE IMPLANTED DURING THE SURGERY. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Unspecified Infection
MAUDE report 18190193 ↗
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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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