Arthrex® AR-8737-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867127135), received between Feb 1, 2021 and Jan 19, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJan 19, 2024Unexpected Color; Unexpected Color

  ON 12/22/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06437969 THAT THE COLORING FOR THE SIZE IDENTIFICATION IS A DIFFERENT COLOR. THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546468 ↗
• InjuryDec 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON NOVEMBER 3, 2023, IT WAS REPORTED BY THE SURGEON THAT HIS PATIENT MAY BE HAVING AN ALLERGIC REACTION TO THE DEVICES AND/OR INSTRUMENTS USED IN A PRIOR SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ON NOVEMBER 11, 2023, MEDICAL RECORDS WERE PROVIDED CONFIRMING THAT THE SURGEON PERFORMED A BUNIONECTOMY, AND 1ST METATARSAL OSTEOTOMY OF THE LEFT FOOT WAS PERFORMED ON (B)(6) 2020. ARTHREX¿S SALES RECORDS FOR THE PATIENT¿S (B)(6) 2020 PROCEDURE INDICATE THE SCREWS IMPLANTED DURING THE SURGERY WERE ARTHREX¿S AR-8725-24H COMPR FT SCRW,2.5 MICRO,24MM LGTH (LOT 10546665), AR-8730-28H COMPR FT SCRW,3.5 MINI,28MM LGTH (LOT 10279485) AND AR-8730-36H COMPR FT SCRW,3.5 MINI, 36MM (LOT 10443285). FOLLOWING THE INITIAL SURGERY, THE RECORDS INDICATE THAT ON (B)(6) 2023, A SECOND SURGERY WAS PERFORMED BY THE SAME SURGEON TO REMOVE A PROMINENT SCREW IN THE 1ST LEFT METATARSAL. DURING THIS SURGERY, MULTIPLE ARTHREX INSTRUMENTS WERE USED TO ATTEMPT TO REMOVE THE SCREW HOWEVER THE PROCEDURE WAS ABANDONED AS THE SCREW WAS UNABLE TO BE REMOVED FROM THE BONE AFTER MULTIPLE ATTEMPTS WITH DIFFERENT REMOVAL INSTRUMENTS. ALL SCREWS REMAIN IMPLANTED. THOSE INSTRUMENTS HAVE BEEN IDENTIFIED AS ARTHREX¿S AR-8737

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18352163 ↗
• MalfunctionFeb 1, 2021Fracture

  IT WAS REPORTED THAT THE AR-8737-43 AND AR-8737-35 WERE BEING USED FOR A THUMB FUSION CASE. THE GUIDE WIRE WAS IN THE BONE AND WHEN DRILLING, THE GUIDE SLEEVE TORQUED, PULLING THE GUIDE WIRE THROUGH THE BONE FRACTURING IT. ANOTHER MANUFACTURER'S PLATE AND SCREW WERE USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 11259279 ↗