Arthrex® AR-8934BCST-2Recalls & reported problems
Arthrex, Inc. · 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY · Class 2 · Implant
Data updated Oct 18, 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 00888867375123), received between Jun 3, 2024 and Sep 23, 2024 — classified as 3 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
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2024Break; Break
ON 9/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8934BCST-2 DOUBLE LOADED SUTURETAPE S-TAK ASSY TIP OF THE ANCHOR BROKE. THIS WAS DISCOVERED DURING A BROSTROM PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 20280059 ↗MalfunctionJul 9, 2024Break; Crack; Break; Crack
ON 6/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8934BCST-2 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY CRACKED DURING INSERTION OF THE DEVICE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ANOTHER OF THE SAME PRODUCT WAS OPENED FROM A DIFFERENT LOT WITH NO ISSUES. THERE WAS NO DELAY IN THE CASE. THIS WAS DISCOVERED DURING A LATERAL ANKLE INSTABILITY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19703339 ↗MalfunctionJun 3, 2024Crack; Crack
ON 5/6/2024 A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8934BCST-2 3.0 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY CRACKED WHEN TAPPING IN THE BONE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT WITH A SLIGHT DELAY. THE CASE WAS COMPLETED USING ANOTHER AR-8934BCST-2 3.0 3.0 DOUBLE LOADED SUTURETAPE FROM AN UNKNOWN LOT WITH NO ISSUES. THIS WAS DISCOVERED DURING AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19447712 ↗
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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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