Arthrex® AR-8610D-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867197299), received between Nov 30, 2021 and Apr 28, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING THE ANKLE ARTHRODESIS, THE TIP OF THE SCREWDRIVER TWISTED AND BROKE OFF WHILE THE SCREW (6.5 MM HEADLESS COMPRESSION SCREW) WAS BEING INSERTED. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. IN ADDITION, A GUIDE WIRE (NOT AN ARTHREX PRODUCT) BECAME LODGED IN THE SCREWDRIVER. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020946 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING THE ANKLE ARTHRODESIS, THE SCREWDRIVER BROKE WHILE THE SCREW (6.5 MM HEADLESS COMPRESSION SCREW) WAS BEING INSERTED. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020748 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE TIP OF THE DEVICE BROKE OFF WHILE USING THE DEVICE IN THE PATIENT. ALL FRAGMENTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 23880060 ↗
• MalfunctionJul 2, 2025Break; Break

  ON 06/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8610D-65 DRIVE SHAFT BROKE DURING INSERTION. ISSUE DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386285 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL TUBERCLE TRANSFER THE SURGEON DRILLED & COUNTERSUNK APPROPRIATELY. THE SURGEON BEGAN INPUTTING THE SCREW WITH A POWER TOOL AND THEN THEN CHANGED FOR THE FINAL TENSIONING TO A SCREWDRIVER. DURING THE TENSIONING THE DEVICE BROKE OFF INSIDE THE SCREW. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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 18110927 ↗
• MalfunctionJun 19, 2023Break; Break

  ON 05/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8610D-65 DRIVER SHAFT BROKE. THIS OCCURRED DURING A TRIPLE ARTHRODESIS ON (B)(6) 2023 WHILE TRYING TO ADVANCE A 6.5MM COMP PT SCREW BEING USED FOR A SUBTALAR FUSION. THE CASE WAS COMPLETED USING ANOTHER DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 17152488 ↗
• MalfunctionSep 6, 2022Break

  SCREW DRIVER HANDPIECE BROKE. NO FURTHER INFORMATION AVAILABLE. MORE INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362506 ↗
• MalfunctionJan 31, 2022Break

  IT WAS REPORTED THAT DURING A SCREW REMOVAL THE DRIVER SHAFT BECAME TWISTED AND SNAPPED OFF DURING THE REMOVAL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13397855 ↗
• MalfunctionJan 31, 2022Break

  IT WAS REPORTED THAT DURING A FOOT FIXATION SURGERY THE TIP OF THE DRIVER TWISTED AND BROKE OFF DURING THE SCREW INSERTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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 13397424 ↗
• MalfunctionJan 31, 2022Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A FOOT FIXATION SURGERY THE TIP OF THE DEVICE GOT TWISTED AND BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13397411 ↗
• MalfunctionJan 31, 2022Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A FOOT FIXATION SURGERY THE TIP OF THE DRIVER TWISTED AND BROKE DURING THE INSERTION OF THE SCREW. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13397407 ↗
• MalfunctionJan 31, 2022Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE TIPS OF TWO DRIVER BROKE OFF WHILE THE SURGEON TRIED TO INSERT THE SCREWS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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 13397321 ↗
• MalfunctionNov 30, 2021Break

  IT WAS REPORTED THAT DURING A CALCANEAL SURGERY THE SURGEON DIDN`T USE POWER TOOLS WITH THE DEVICE BUT HAND TIGHTENING AND THE PICTURES SHOW, THAT THE TIP OF THE DEVICE BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897038 ↗