Arthrex® AR-1322BCNF-1Recalls & reported problems
Arthrex, Inc. · SUTR ANCH MICRO BIO-COMP S-TAK 2.4X 8.5 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867088573), received between Jul 17, 2018 and Jul 17, 2018 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Difficult to Remove1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2018Break; Difficult to Remove
IT WAS REPORTED THAT THERE WAS A METAL BREAK AT THE TIP. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN FRAGMENT. IT WILL REMAIN INSIDE THE BONE. THE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. ADDITIONAL INFORMATION OBTAINED: PERFORMED SURGERY WAS AN BROSTRÖM ANKLE JOINT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7693329 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- 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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