Arthrex® AR-8770-02-RURecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867319592), received between Dec 26, 2023 and Sep 28, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914896 ↗
• MalfunctionMay 26, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE DRILL BIT BROKE OFF. 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. UPDATE 12-MAY-2026: DURING INCOMING INSPECTION OF THE RETURNED DEVICES, IT WAS FOUND THAT THE INITIALLY PROVIDED COMPLAINT INFORMATION WAS INCORRECT. DURING THE VISUAL EVALUATION IT WAS FOUND THAT THE DRILL BIT BECAME STUCK INSIDE THE GUIDE AND NO PART OF THE DEVICE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283487 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE DRILL BROKE OFF AT THE PROXIMAL END. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 27-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING A SURGERY, THE DRILL BROKE OFF AT THE PROXIMAL END. NO FRAGMENTS REMAINED IN THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT USING 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 24845020 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE DRILL BROKE OFF AT THE PROXIMAL END. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 27-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING A SURGERY, THE DRILL BROKE OFF AT THE PROXIMAL END. NO FRAGMENTS REMAINED IN THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT USING 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 24844810 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE DRILL BIT TAIL PIECE BROKE WHILE USING IN AO ADAPTER. NO BROKEN PART FELL INTO THE PATIENT. 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 23646871 ↗
• MalfunctionOct 30, 2025Break; Break

  ON 10/21/2025, A DISTRIBUTOR REPORTED VIA (B)(4) THAT AN AR-8770-02-RU 5MM REUSABLE CANNULATED DRILL BIT BROKE DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423614 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE DEVICE BROKE. ALL PARTS 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 21618967 ↗
• MalfunctionOct 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING MULTIPLE EVENTS THE CUSTOMER EXPERIENCED ISSUES WITH THE DRILL GUIDE AND THE K-WIRE. THE DRILL BECAME STUCK AND PUSHED THE GUIDEWIRE FURTHER INTO THE JOINT THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION HOW MANY EVENTS WITH THE REPORTED EVENT HAS OCCURED. THE CUSTOMER REPORTED FURTHER THAT THE ISSUE ALWAYS WITH AN AR-8770-02RU BUT THE CUSTOMER EXPERIENCED THE SAME ISSUE WITH THE AR-8770K AND AR-8770KT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506820 ↗
• MalfunctionOct 14, 2024Device Damaged by Another Device; Physical Resistance/Sticking; Device Damaged by Another Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SUBTALAR ARTHRODESIS SURGERY THE CUSTOMER EXPERIENCED ISSUES WITH THE DRILL GUIDE AND THE K-WIRE. THE AR-8770-02-RU CANNULATED DRILL PASSES OVER THE AR-8770K K-WIRE WHEN TESTED, BEFORE STARTING THE PROCEDURE. DURING THE PROCEDURE, WHEN THE PROXIMAL CORTEX IS DRILLED OVER THE GUIDE WIRE, THE DEVICES ARE NO LONGER COMPATIBLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHTHE SAME 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 20439395 ↗
• MalfunctionJul 24, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A SUB-TALAR JOINT FUSION THERE WERE TWO BLUNT 5MM DRILLS (AR-8770-02-RU) ON THE 5/7 MM COMP FT SET. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 19815258 ↗
• MalfunctionJul 24, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A SUB-TALAR JOINT FUSION THERE WERE TWO BLUNT 5MM DRILLS (AR-8770-02-RU) ON THE 5/7 MM COMP FT SET. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 19815156 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL BROKE DURING SUBTALAR ARTHROSCOPY WHEN OVER-DRILLING THE K-WIRE AND APPLYING FORCE IN THE AO JUNCTION WITHIN THE APPROACH. THE SURGEON THOUGHT THAT THE DRILL WAS BLUNT AND THEREFORE HE HAD TO APPLY MORE FORCE. HOWEVER, THE FORCE APPLIED WAS NOT SO STRONG THAT THE DRILL COULD HAVE BROKEN. THE OTHER DRILL, WHICH APPEARED TO BE SHARPER, WAS THEN USED WITHOUT ANY PROBLEMS. 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. UPDATE NROE 15-DEC-2023: FURTHER INFORMATION REVEALED THAT A SMALL PART STUCK IN THE ATTACHMENT. THE MAIN PART WAS RETRIEVED OFF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474026 ↗
• MalfunctionDec 26, 2023Break; Material Fragmentation; Break; Material Fragmentation

  UPDATE DW 22-JAN-2024: FURTHER INFORMATION WERE PROVIDED THAT THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT ANY COMPLICATIONS. SURGEON SAW THE SMALL FRAGMENT WHICH REMAINED INSIDE OF THE PATIENT WHEN HE MADE LAST CONTROL X-RAY SCREENING IN THE END OF THE SURGERY. THERE WAS NO CHANCE TO REMOVE THE FRAGMENT BECAUSE THE SURGEON ALREADY SUTURED UP THE INCISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18394862 ↗