Arthrex® AR-8730-36HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867303300), received between Feb 11, 2020 and Dec 18, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ON (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 ARTHRE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18352039 ↗
• InjuryFeb 11, 2020Break

  FEMALE PATIENT (UNKNOWN AGE) HAD A LAPIDUS BUNION PROCEDURE ON HER RIGHT FOOT ON (B)(6) 2019. SHE COMPLAINED OF PAIN AND AN X-RAY SHOWED THAT THE AR-8730-36H SCREW HAD BROKEN. THERE WAS A SECOND SURGERY DONE ON (B)(6) 2020 AND A PARTIAL OF THE BROKEN SCREW WAS REMOVED FROM THE PATIENT. THERE IS A FRAGMENT REMAINING IN THE MIDDLE OF THE BONE INTERMEDIATE CUNEIFORM. ALSO REMOVED WAS THE PLATE AR-8941, SCREWS AR-8935L-16 X2, AR-8935L-18 X1 AND AR-8940-22 X1. NOTHING ELSE WAS IMPLANTED AFTER THE PLATE AND SCREWS WERE REMOVED. CALLER WAS UNAWARE OF ANY POST-OP NON-COMPLIANCE.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 9695037 ↗