Arthrex® AR-7221Recalls & reported problems
Arthrex, Inc. · FIBERWIRE, BRAIDED PB 2-0 SUTURE, BLUE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041493), received between Apr 27, 2021 and Oct 28, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7221 FIBERWIRE # 2-0 AND AN AR-2324PSLC PEEK SWIVELOCK C SUTURE ANCHOR CAME OUT OF THE HOLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/15/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404798 ↗MalfunctionApr 27, 2021Break
IT WAS REPORTED THAT DURING A MENISCAL PROCEDURE, THE SURGEON USED QTY. 4 OF THE FOLLOWING: AR-7721, AR-7235, AR-12990N, AND ALL 12 DEVICES BROKE WHEN USED WITH THE KNEE SCORPION. THE CASE WAS COMPLETED BY USING NEW DEVICES.
Patient problems: Insufficient Information
MAUDE report 11730937 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
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- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 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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