Arthrex® AR-8770-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00888867263789), received between Jun 7, 2018 and Jun 16, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT DURING THE FOOT DISTRACTION ARTHROPLASTY, THE TIP OF THE SCREW DRIVER BROKE OFF. 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 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 25524564 ↗
• MalfunctionFeb 5, 2026Break

  ON 15-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8770-01 T25 HEXALOBE, CANNULATED DRIVER SHAFT BROKE WHILE EXTRACTING A SCREW. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268553 ↗
• MalfunctionOct 31, 2025Break; Break

  ON 28TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8770-01, DRIVER SHAFT, T25 HEXALOBE, CANNULATED, ISO, TRILOBE, BROKE. THE SCREWDRIVER WAS LOADED CORRECTLY INTO THE HAND PIECE, AND THE SCREW WAS ATTACHED CORRECTLY TO THE SCREWDRIVER TIP. MINIMAL FORCE WAS USED WHEN THE TIP OF THE SCREWDRIVER BROKE OFF. THIS WAS DETECTED DURING A CALCANEAL OSTEOTOMY AND MEDIAL SHIFT PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A SECONDARY SCREWDRIVER WAS USED FROM THE TRAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23440118 ↗
• MalfunctionJun 26, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-8770-01 T25 HEXALOBE DRIVERS BROKE UPON INSERTION OF THE 7.0 HEADLESS XL SCREWS. THE TIPS OF EACH DRIVER SNAPPED OFF WHILE TRYING TO IMPLANT THE SCREWS FOR A MEDIAL CALCANEAL SLIDE DURING A STAGE 2 FLATFOOT PROCEDURE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337597 ↗
• MalfunctionJun 26, 2025Break; Break

  ON 06/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-8770-01 T25 HEXALOBE DRIVERS BROKE UPON INSERTION OF THE 7.0 HEADLESS XL SCREWS. THE TIPS OF EACH DRIVER SNAPPED OFF WHILE TRYING TO IMPLANT THE SCREWS FOR A MEDIAL CALCANEAL SLIDE DURING A STAGE 2 FLATFOOT PROCEDURE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337436 ↗
• MalfunctionJun 26, 2025Break; Break

  ON 06/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-8770-01 T25 HEXALOBE DRIVERS BROKE UPON INSERTION OF THE 7.0 HEADLESS XL SCREWS. THE TIPS OF EACH DRIVER SNAPPED OFF WHILE TRYING TO IMPLANT THE SCREWS FOR A MEDIAL CALCANEAL SLIDE DURING A STAGE 2 FLATFOOT PROCEDURE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337311 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE DEVICE BROKE. 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 21618969 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE DEVICE BROKE. 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 21618966 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE SURGERY THE DRIVER HEAD BROKE OFF WHILE SCREWING. ALL PARTS 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 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 20798300 ↗
• MalfunctionJul 15, 2024Break; Break

  ON 6/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8770-01 DRIVER SHAFT (COMPONENT SET OF AR-8750S LOT 15187400) SNAPPED DURING USE AND ALL FRAGMENTS WERE RETRIEVED, AND AN AR-8750-03 DRIVER SHAFT SNAPPED DURING USE AND ALL FRAGMENTS WERE RETRIEVED. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740225 ↗
• MalfunctionMay 17, 2024Break; Break

  ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8770-01 DRIVER SHAFT TIP BROKE OFF. THIS OCCURRED DURING A PROCEDURE WHERE THE FRAGMENT WAS RETRIEVED. THE DEVICE WAS SWITCHED OUT AND THE CASE COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 19345039 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A CALCANEUS OSTEOTOMY SURGERY ONE PRONG OF THE TORX BROKE OFF AT THE FRONT WHEN INSERTING THE SCREW. NO FRAGMENTS REMAINED IN THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19096002 ↗
• MalfunctionFeb 9, 2024Break; Break

  ON 01/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8770-01 DRIVER SHAFT BROKE. THIS OCCURRED DURING A SUBTALAR JOINT FUSION ON (B)(6) 2024 WHEN INSERTING THE SCREW THE DRIVER BROKE. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED USING THE THE SOLID DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 18678015 ↗
• MalfunctionFeb 9, 2024Break; Break

  ON 01/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8770-01 DRIVER SHAFT BROKE. THIS OCCURRED DURING A SUBTALAR JOINT FUSION ON (B)(6) 2024 WHEN INSERTING THE SCREW THE DRIVER BROKE. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED USING THE SOLID DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 18678004 ↗
• MalfunctionFeb 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A SUBTALAR ARTHRODESIS SURGERY THE SCREWDRIVER BROKE. 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. UPDATE DW 12-JAN-2024: FURTHER INFORMATION WERE PROVIDED THAT THE BROKEN FRAGMENT WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630058 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE BIT OF THE SCREWDRIVER BROKE OFF WHILE INSERTING THE SCREW INTO 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 18359136 ↗
• MalfunctionDec 8, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8770-01 DRIVER SHAFT T25 HEXALOBE BROKE INSIDE A 7.0 HEADLESS COMPRESSION SCREW DURING INSERTION OF THE SCREW. THE BROKEN FRAGMENTS WERE REMOVED FROM THE SCREW, AND THE SCREW REMAINED IMPLANTED WITHOUT ISSUE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING A SUBTALAR FUSION PROCEDURE ON 11/14/2023. THE HEXALOBE DRIVER SHAFT BROKE INSIDE AN AR-8770-XXH SCREW; THE SIZE IS UNKNOWN, AND THE SCREW REMAINED IMPLANTED. THE CASE WAS DELAYED FOR ABOUT FIVE MINUTES, AND ANESTHESIA WAS ADMINISTERED FOR THAT TIME. THE PATIENT SUFFERED NO SIGNIFICANT SYMPTOMS OR NEGATIVE EFFECTS ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293072 ↗
• MalfunctionSep 27, 2023Break; Break

  ON 8/30/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. IT WAS ANONYMOUSLY REPORTED THAT AN AR-8770-01 DRIVER SHAFT HEAD BROKE DURING HARDWARE REMOVAL. THE BROKEN FRAGMENTS WERE REMOVED AND AN X-RAY WAS TAKEN TO CONFIRM THE OBJECT WAS REMOVED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17826946 ↗
• MalfunctionAug 16, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE TIP OF THE DEVICE SNAPPED WHILST SCREWING. ALL BROKEN PARTS 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 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 17555929 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE TIP OF THE DEVICE SNAPPED WHILST SCREWING. ALL BROKEN PARTS 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 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 17480291 ↗
• MalfunctionJul 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE DEVICE BROKE OFF WHEN SCREWING A SCREW INTO THE CALCANEUS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 AVOE (B)(6) 2023 IT WAS CONFIRMED THAT NO PART OF THE DEVICE BROKE OFF. THE DEVICE CRACKED AND NO PART OF THE DEVICE HAD TO BE REMOVED FROM THE PATIENT. UPDATE AVOE (B)(6) 2023 FURTHER INFORMATION WAS PROVIDED THAT A PART OF THE DEVICE BROKE OFF, SINCE HALF OF THE TORX ATTACHMENT IS MISSING FROM THE DEVICE. NO FRAGMENTS REMAINED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246476 ↗
• MalfunctionFeb 6, 2023Break

  IT WAS REPORTED ON 01/18/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8770-01 T25 HEXALOBE HEAD BROKE OFF DURING INSERTION BY HAND, OF AR 8770-80 IN A SUBTALAR FUSION. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 16303032 ↗
• MalfunctionJan 16, 2023Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8770-01 DRIVER SHAFT, T25 HEXALOBE, CANNULATED HAD AN ISSUE, THE TIP OF THE DRIVER SHAFT BROKE OFF. THIS OCCURRED DURING AN ANKLE FUSION PROCEDURE ON (B)(6) 2022. NO PIECE BROKE OFF INSIDE THE PATIENT, THE DEVICE BROKE DURING USE, THERE WAS NO HARM, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION OVER THE PHONE: WHEN THE TIP OF THE DRIVER SHAFT BROKE OFF, IT DID BREAK OFF INSIDE THE PATIENT, BUT ALL FRAGMENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173466 ↗
• MalfunctionDec 27, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8770-01 DRIVER SHAFTS TIP BROKE OFF. THIS OCCURRED DURING AN ANKLE FUSION PROCEDURE ON (B)(6) 2022 WHEN THERE WAS A BIT OF A STRUGGLE INSERTING THE SCREW, AND X-RAY WAS TAKEN WHERE IT SHOWED THE SCREW COUNTERSUNK. THEY WENT TO REVERSE THE SCREW, AND THE DRIVER TIP BROKE OFF. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051404 ↗
• MalfunctionDec 6, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8770-01 DRIVER SHAFT, AND A AR-8943-08 SCREWDRIVER BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923847 ↗