Arthrex® AR-8737-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00888867127166), received between Sep 28, 2016 and Jul 7, 2026 — classified as 10 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Break” (77 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 23-JUN-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE META OSTEOSYNTHESIS, THE DEVICE IS BROKEN. 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 DO A SECOND SURGERY. UPDATE 25-JUN-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738192 ↗
• InjuryMay 20, 2026

  SCREWDRIVER TIP BROKE OFF DURING SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241373 ↗
• MalfunctionApr 6, 2026Break

  ON (B)(6) 2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8737-38 T10 HEXALOBE SHAFT BROKE DURING A HARDWARE REMOVAL. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792191 ↗
• MalfunctionApr 6, 2026Break

  ON 12-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8737-38 T10 HEXALOBE SHAFT BROKE DURING A HARDWARE REMOVAL. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792054 ↗
• MalfunctionApr 2, 2026Break

  ON 12-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA SEM-(B)(4) THAT AN AR-8737-38 T10 HEXALOBE SHAFT BROKE DURING A HARDWARE REMOVAL. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769869 ↗
• MalfunctionFeb 5, 2026Break

  ON 15-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-8737-38 T10 HEXALOBE TIPS OF DRIVER SHAFTS BROKE OFF WHEN INSERTING THE SCREW. BOTH PIECES WERE REMOVED. THIS WAS DISCOVERED DURING A TTO CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269298 ↗
• MalfunctionFeb 5, 2026Break

  ON 15-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-8737-38 T10 HEXALOBE TIPS OF DRIVER SHAFTS BROKE OFF WHEN INSERTING THE SCREW. BOTH PIECES WERE REMOVED. THIS WAS DISCOVERED DURING A TTO CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269091 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED DURING THE MINIMALLY INVASIVE CHEVRON AND AKIN SURGERY THAT THE DRIVER SHAFT BROKE OFF WHILE INSERTING THE SCREW. 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 23681433 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 11/3/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-38 HEXALOBE SCREWDRIVER HAS TWISTED AT BOTH TIPS. NO DAMAGE TO THE SCREW, AND THE CASE WAS ABLE TO BE COMPLETED WITH A REPLACEMENT REMOVAL SCREW SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630909 ↗
• MalfunctionNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 11/3/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-38 HEXALOBE SCREWDRIVER HAS TWISTED AT BOTH TIPS. NO DAMAGE TO THE SCREW, AND THE CASE WAS ABLE TO BE COMPLETED WITH A REPLACEMENT REMOVAL SCREW SET.

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

  MAUDE report 23618593 ↗
• MalfunctionJul 25, 2025Break; Break

  ON 7/3/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT TWO AR-8737-38 DRIVER SHAFT TIPS BROKE INTRAOPERATIVELY WHILE IN USE ON A PATIENT. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY RETRIEVED AND CONFIRMED VIA CLEAR RADIOGRAPHIC IMAGING. NO HARM TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 7/14/2025: THE PATIENT UNDERWENT A LEFT TRIPLE ARTHRODESIS. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES, AND THERE WAS NO DELAY IN SURGERY. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612517 ↗
• MalfunctionJul 25, 2025Break; Break

  ON 7/3/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT TWO AR-8737-38 DRIVER SHAFT TIPS BROKE INTRAOPERATIVELY WHILE IN USE ON A PATIENT. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY RETRIEVED AND CONFIRMED VIA CLEAR RADIOGRAPHIC IMAGING. NO HARM TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 7/14/2025: THE PATIENT UNDERWENT A LEFT TRIPLE ARTHRODESIS. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES, AND THERE WAS NO DELAY IN SURGERY. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612465 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SCREW EXTRACTION SURGERY THE DRILL BROKE DURING OPERATION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAMPLE 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 21342576 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SCREW EXTRACTION SURGERY THE DRILL BROKE DURING OPERATION. 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 21342540 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A SCREW REMOVAL THE TIP OF 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 21137739 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A SCREW REMOVAL THE TIP OF 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 21137619 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06734836 THAT (QTY. 3) OF AN AR-8737-38 DRIVER SHAFT, T10 HEX, CANNULATED BROKE WHEN ATTEMPTED TO REMOVE THREE 3.5 FULLY THREADED HEADLESS COMPRESSION SCREWS IN THE MIDFOOT REGION WHILE USING PROPER TECHNIQUE. THEY TRIED TO USE THE ARTHREX MINI TREPHINE, AND AFTER MANY ATTEMPTS, THEY USED A NON-ARTHREX PRODUCT TO CORE AROUND THE HEADLESS COMPRESSION SCREWS TO REMOVE THEM. NO PIECES BROKE OFF INSIDE THE PATIENT REPORTED. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A MIDFOOT HARDWARE REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113985 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06734836 THAT (QTY. 3) OF AN AR-8737-38 DRIVER SHAFT, T10 HEX, CANNULATED BROKE WHEN ATTEMPTED TO REMOVE THREE 3.5 FULLY THREADED HEADLESS COMPRESSION SCREWS IN THE MIDFOOT REGION WHILE USING PROPER TECHNIQUE. THEY TRIED TO USE THE ARTHREX MINI TREPHINE, AND AFTER MANY ATTEMPTS, THEY USED A NON-ARTHREX PRODUCT TO CORE AROUND THE HEADLESS COMPRESSION SCREWS TO REMOVE THEM. NO PIECES BROKE OFF INSIDE THE PATIENT REPORTED. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A MIDFOOT HARDWARE REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113975 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06734836 THAT (QTY. 3) OF AN AR-8737-38 DRIVER SHAFT, T10 HEX, CANNULATED BROKE WHEN ATTEMPTED TO REMOVE THREE 3.5 FULLY THREADED HEADLESS COMPRESSION SCREWS IN THE MIDFOOT REGION WHILE USING PROPER TECHNIQUE. THEY TRIED TO USE THE ARTHREX MINI TREPHINE, AND AFTER MANY ATTEMPTS, THEY USED A NON-ARTHREX PRODUCT TO CORE AROUND THE HEADLESS COMPRESSION SCREWS TO REMOVE THEM. NO PIECES BROKE OFF INSIDE THE PATIENT REPORTED. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A MIDFOOT HARDWARE REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113491 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN OSTEOSYNTHESIS 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 20633844 ↗
• MalfunctionNov 4, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN EXTRACTION OF METALS AFTER AN ARTHRODESIS SURGERY ONE 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 20600770 ↗
• MalfunctionNov 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN EXTRACTION OF METALS AFTER AN ARTHRODESIS SURGERY A SECOND DEVICE WAS BENT. 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 20600460 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE TIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 19973290 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE TIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 19973200 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A FIRST METACARPOPHALANGEAL (MTP) ARTHRODESE WHEN REMOVING A 4.00MM COMP. FT SCREW THE SCREW DRIVER BROKE, BUT NOT INSIDE PATIENT. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489780 ↗