Arthrex® AR-8737-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867046214), received between Apr 26, 2021 and Aug 28, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495283 ↗
• MalfunctionOct 17, 2022Material Fragmentation

  IT WAS REPORTED THAT DURING A SYNDESMOSES SURGERY THE TIP OF DRIVER SHAFT TWISTED COMPLETELY AND A SMALL PIECE BROKE OFF. ALL THE FRAGMENTS WERE RETRIEVED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR PERFORM A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615234 ↗
• MalfunctionAug 18, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY FOUR DRIVERS BROKE DURING REMOVAL OF THE SCREW. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. UPDATE (B)(6) 2022: REMOVAL OF PLATE AND SCREWS WAS PERFORMED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD-PARTY. ANOTHER SCREW DRIVER WAS USED TO FINISH THE SURGERY SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 2022: THE PART AND LOT NUMBERS OF BROKEN DRIVERS WERE RECEIVED: AR-8610D-25, LOT 6045184103. AR-8737-25, LOT 01391809. AR-8610D-30, LOT (10)1392150. AR-8737-26, LOT (10)1392118.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249496 ↗
• MalfunctionMay 3, 2022Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE TIP BROKE OFF INSIDE THE PATIENT WHEN TURNING OUT THE SCREW. THE BROKEN PIECE WAS REMOVED FROM PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. 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 14269993 ↗
• MalfunctionApr 26, 2021Detachment of Device or Device Component

  IT WAS REPORTED THE SURGEON WAS ATTEMPTING TO IMPLANT AR-8740-38H STANDARD HEADLESS SCREW. AFTER THE SURGEON DRILLED AND PROFILE DRILLED OVER A K-WIRE, THE SCREW WOULD NOT GET FLUSH. X-RAY WAS TAKEN TO VERIFY THAT IT WAS NOT TOO LONG AND IT WAS CONFIRMED THAT IS WAS NOT. THE SURGEON WENT BACK TO THE SCREW AND TRIED TO SCREW IT IN MORE, AND THE AR-8737-38 DRIVER TIP SNAPPED OFF IN THE SCREW. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE AND USED ANOTHER DRIVER AR-8737-26 TO TRY TO COMPLETE THE SURGERY AND IT ALSO SNAPPED OFF AT THE END OF THE DRIVER TIP. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE FROM THE SCREW. ANOTHER SCREW DRIVER SET WAS OPENED AND THE SURGEON USED A NON-CANNULATED DRIVER TIP TO ADVANCE THE SCREW SO THAT IT WAS FLUSH WITH THE BONE.

  Patient problems: Insufficient Information

  MAUDE report 11724894 ↗