Arthrex® AR-7230-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867041615), received between Aug 31, 2021 and Apr 18, 2022 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2022Detachment of Device or Device Component

  (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-7230-01 FIBERWIRE® #4-0, BRAIDED POLYBLEND SUTURE, BLUE, WITH TAPERED POINT NEEDLE HAD AN ISSUE. DURING A WOUND EXPLORATION POSSIBLE NERVE REPAIR (B)(6) 2022, WHEN WORKING ON HAND, APPROXIMATING THE TENDON BACK TOGETHER, WHEN PULLING SUTURE THROUGH HAND, THE NEEDLE DETACHED FROM SUTURE MID PASS. THE PIECE BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135815 ↗
• MalfunctionJan 4, 2022Defective Component

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-7230-01 FIBERWIRE IS NOT STICKING. THIS OCCURRED DURING A FINGER OPERATION, THE SURGEON USED IT TO SUTURE A TENDON BUT COULDN'T USE IT BECAUSE THE NEEDLE WOULD NOT STICK. THE CASE WAS COMPLETED USING A NEW PRODUCT, THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED 11/02/2021: DOCTOR OPENED THE NEW AR-7230-01 AND WAS ABLE TO FIX IT SAFELY. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152459 ↗
• MalfunctionAug 31, 2021Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT WITH THE REPORTED DEVICE THE NEEDLE CAME OFF THE SUTURE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. (B)(6) 2021 UPDATE: IT WAS CONFIRMED THAT DURING AN ARTHROSCOPY SURGERY WITH THREE DEVICES AR-7230-01 (LOT 23869) THE NEEDLE BROKE OFF THE SUTURE INSIDE THE PATIENT. ACCORDING TO THE DESCRIPTION FROM THE CUSTOMER THE NEEDLES STUCK IN THE PATIENT AND WHEN THE SUTURES WERE TIGHTENED, THE SUTURE TORE FROM THE NEEDLE. SUBSEQUENTLY THE NEEDLES WERE REMOVED FROM THE PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 12392680 ↗