Arthrex® AR-8730-30HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867127043), received between May 24, 2021 and Jun 7, 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.

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.

• MalfunctionJun 7, 2024Break; Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A PATIENT UNDERWENT A FIRST MTP JOINT FUSION ON (B)(6) 2021 AND ON THE PATIENTS NORMAL FOLLOW-UP THIS WEEK, AN X-RAY SHOWS THAT BOTH SCREWS HAVE BROKEN AND THE JOINT HAS NOT FUSED. ATTACHED ARE THE X-RAYS FROM THE POST-OP VISIT. NO ADDITIONAL INFORMATION. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 09/29/2021: THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2021 FOR A FIRST MTP FUSION. THE PRIMARY PROCEDURE TOOK PLACE AT (B)(6) SURGICENTER, ARTHREX ACCOUNT (B)(4). THE IMPLANTED DEVICE(S) WERE AR-8730-32H AND AR-8730-30H. IF THE PATIENT AGREES TO A SECOND SURGERY, THEN THE BROKEN SCREWS WOULD BE REMOVED. THE PATIENT IS CURRENTLY SEEKING A SECOND OPINION. NO REVISION SCHEDULED AS THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 19490025 ↗
• MalfunctionFeb 16, 2023Break

  IT WAS REPORTED THAT DURING A SURGERY DURING INSERTION THE SCREW BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385078 ↗
• MalfunctionMay 24, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2020 THE TIP OF A AR-8737-37 (LOT: 1391933) BROKE OFF IN THE HEAD OF THE AR-8730-30H (LOT: 10668937) SCREW. WHEN THE BREAKAGE OCCURRED, THE SCREW WAS UNABLE TO BE FULLY SEATED AND WAS LEFT PROUD. THE SURGEON REMOVED THE SCREW ON (B)(6) 2021 USING ANOTHER MANUFACTURER'S REMOVAL SYSTEM. THE REP REPORTED THERE WERE NO ARTHREX PRODUCTS IMPLANTED DURING THE REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 11871768 ↗