Arthrex® AR-7200-1Recalls & reported problems
Arthrex, Inc. · FW,BPB #2 SUTR,BLU W/NDL · Class 2 · Implant
Data updated Oct 16, 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 00888867280908), received between Aug 17, 2022 and Jun 27, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2024Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SUTURING OF THE MENISCUS THE SUTURE BROKE WHILE TIGHTENING THE LOOP. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629465 ↗MalfunctionJan 10, 2024Expiration Date Error; Expiration Date Error
ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN EXPIRED AR-7200-1, FIBERWIRE® #2 BRAIDED POLYBLEND SUTURE, BLUE, W/ TAPERED NEEDLE, IMPLANT WAS USED ON PATIENT. THIS WAS DETECTED ON (B)(6) 2023 DURING A LEFT MENISCAL REPAIR PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 18486078 ↗MalfunctionAug 17, 2022Break
IT WAS REPORTED THAT DURING A ANTERIOR CRUCIATE LIGAMENT SURGERY THE THREAD WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15242578 ↗
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- 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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