Arthrex® AR-8737-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867263802), received between Jan 20, 2020 and Jan 6, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Break; Break

  ON 12/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-61 SCREW REMOVER, EASY-OUT, 2.5 MICRO COMPRESSION FT HAD THE TIP BREAK (FROM THEIR HEADLESS COMPRESSION SCREW SET #3). THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084157 ↗
• 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 (B)(6) 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 SCREW,2.5 MICRO,24MM LGTH (LOT 10546665), AR-8730-28H COMPR FT SCREW,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-8737-35

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18352186 ↗
• MalfunctionDec 13, 2021Break; Entrapment of Device

  ON 11/24/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-8737-37 SHAFT TIP BROKE OFF, AND A AR-8737-61 SCREW REMOVER TIP BROKE. THIS OCCURRED ON (B)(6) 2021 DURING A METACARPAL FRACTURE WHILE INSERTING THE 2.5MMX50MM INTO THE 4TH METACARPAL THE CANAL OF THE METACARPAL IT WAS VERY TIGHT. THE METACARPAL WAS PREPARED WITH THE CORRECT CORRESPONDING DRILL BIT FOR THE 2.5MM HEADLESS COMPRESSION FT SCREW. WHILE INSERTING THE SCREW THE CANNULATED SCREW DRIVER TIP (AR-8737-37) BROKE OFF AND WAS THEN REMOVED. THE SURGEON THEN PROCEEDED TO USE THE SOLID SCREW DRIVER IN THE SET TO CONTINUE INSERTING THE SCREW. THE SCREW BECAME TIGHT IN THE SHAFT OF THE 4TH METACARPAL AND OF THE APPROXIMATELY 4MM OF THE SCREW BROKE. THE HEADLESS, BROKEN PORTION OF THE SCREW WAS REMOVED. THE SURGEON CONTINUE USING THE CORRESPONDING EASY OUT (AR-8737-61) TO TRY AND REMOVE THE PORTION OF THE SCREW THAT WAS STILL IN THE 4TH METACARPAL, AND THE EASY OUT TIP BROKE UPON TRYING TO REMOVE THE SCREW AND THE SMALL PORTION OF THE TIP WAS LEFT INSIDE OF THE CANNULATED PORTION OF THE SCREW. THE SCREW WAS LEFT IN THE 4TH METACARPAL AS COMPRESSION ACROSS THE FRACTURE SITE WAS ACHIEVED. THE SCREW REMAINS IN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12984855 ↗
• MalfunctionMay 18, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF DURING THE ANCHOR IMPLANT. THE SITE HAD BEEN PRE-DRILLED. THE TIP WAS RETRIEVED. THEY TRIED TO USE THE AR-8737-61 TO REMOVE THE ANCHOR, BUT THE METAL IN THE DEVICE STARTED TO SPLINTER. THE ANCHOR WAS REMOVED WITH PLIERS. AND THE ANCHOR WAS REMOVED WITH PLIERS. ANOTHER ANCHOR WAS USED TO COMPLETE THE BUNION CASE. PATIENT IS FEMALE, (B)(6) YEARS WITH HARD BONE.

  Patient problems: Insufficient Information

  MAUDE report 11841670 ↗
• InjuryJan 20, 2020Break

  IT WAS REPORTED BY THE SALES REP, THAT DURING A METATARSAL FRACTURE REPAIR PROCEDURE, THE SURGEON PREPARED THE INSERTION SITE USING A 2.2 DRILL, THE AR-8725-50H SCREW WAS INSERTED, AS THE SURGEON MADE THE FINAL TURNS, TO COUNTERSINK THE SCREW IT BROKE APPROXIMATELY 19-20 MM FROM THE DRIVE INSERTION POINT. THE SURGEON USED AN AR-8737-61, EASY OUT TOOL, ON POWER TO TRY AND RELEASE THE SCREW AND THE TIP OF THE DRIVER BROKE. THE PORTION OF THE SCREW WITH THE DRIVER INSERTION WAS REMOVED. THE REMAINDER OF THE SCREW WAS LEFT IN WITH THE TIP OF THE EASY OUT TOOL STILL IN THE CANNULATION OF THE SCREW. THE CASE WAS COMPLETED WITH THE REMAINDER OF THE SCREW STILL ACROSS THE FRACTURE SITE WITH THE FRACTURE REDUCED. ADDITIONAL INFORMATION OBTAINED 01/06/2020: THE SCREW BROKE BUT THE DRIVER FOR THE SCREW DID NOT BREAK. THE EXTRACTION TOOL BROKE LATER IN THE PROCEDURE. THE REMAINING 30MM OF THE SCREW WAS LEFT IN THE PATIENT, STILL ACROSS THE FRACTURE SITE, WITH THE TIP OF THE EASY OUT TOOL IN THE SCREW'S CANNULATION. THE SURGEON DID NOT NEED TO USE ANY ADDITIONAL SCREWS OR ADDITIONAL INCISIONS. IT WAS A METACARPAL FRACTURE AND THERE WERE LIMITED ACCESS POINTS. THE SURGEON DID NOT NEED TO DO ANYT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9606551 ↗