Arthrex® AR-8737-37Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00888867127159), received between May 10, 2018 and Feb 3, 2026 — classified as 14 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (63 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Break

  ON 12-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-37 1.5 MM HEX, CANNULATED DRIVER SHAFT BROKE OFF IN THE SCREW. IT WAS REPORTED THAT DURING A METACARPAL FRACTURE REPAIR PROCEDURE, BEFORE INSERTING THE 2.5MM COMPRESSION FT SCREW, THE SURGEON DRILLED THE FULL LENGTH OF THE SCREW WITH THE 2.0MM DRILL. UPON INSERTION, THE SURGEON HAD DIFFICULTY ADVANCING THE SCREW PAST THE ISTHMUS WHERE THE FRACTURE SITE WAS LOCATED. HE BACKED THE SCREW OUT, RE-DRILLED AND TRIED TO REINSERT THE SCREW. AFTER GETTING THREADS ACROSS THE FRACTURE SITE, A CLICK WAS HEARD WHEN HE TRIED TO CONTINUE ADVANCING THE SCREW. THE DRIVER WAS REMOVED AND IT WAS DETERMINED THAT THE DRIVER SHAFT HAD BROKEN OFF IN THE SCREW. THE COMP FT SCREW WAS REMOVED, AND THE CASE WAS COMPLETED WITH A PLATE AND SCREWS. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM, NO PIECE(S) BROKE OFF IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245306 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A BROKEN TIP OF ARTHREX 1.5 MM CANNULATED SCREWDRIVER IS RETAINED ON THE HEAD OF THE IMPLANTED COMPRESSION FT SCREW, 2.5 MICRO, 28MM LENGTH ON THE PATIENT'S RIGHT SECOND TOE. IT WAS FURTHER REPORTED THAT IT SNAPPED OFF AS THE SURGEON WAS TRYING TO TIGHTEN THE SCREW ON THE BONE. THE BROKEN TIP MIGHT BE AROUND 1MM IN LENGTH OR LESSER. SEVERAL ATTEMPTS WERE DONE TO REMOVE SAID TIP BUT TO NO AVAIL AND THE SURGEON REPORTED THAT IT MIGHT DO MORE DAMAGE TO THE OPERATED TOE. ATTEMPTS WERE MADE TO REMOVE THE BROKEN TIP, BUT IT WAS DIFFICULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24037924 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING A MINIMAL INVASIVE CHEVRON AKIN SURGERY THE SCREWDRIVER BROKE, WHILE INSERTING THE SCREW. ALL PIECES OF THE DAMAGED INSTRUMENT WERE REMOVED. 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 24011513 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED DURING THE OSTEOSYNTHESIS OF METACARPAL FRACTURE THAT THE TIP OF THE DRIVER SHAFT BROKE OFF WHEN THE SCREW WAS BEING INSERTED. THE TIP OF THE DRIVER SHAFT REMAINED STUCK IN THE SCREW, SO THE ENTIRE SCREW WITH THE BROKEN PART WAS REMOVED AND A NEW SCREW WAS USED IN THE SAME HOLE. 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 23726459 ↗
• MalfunctionDec 2, 2025Break; Break

  ON 11/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-37 1.5MM HEX CMP FT TIP BROKE OFF INTO THE SCREW BEFORE IT WAS FULLY ADVANCED AND BEFORE IT COULD BE REMOVED. THE END OF THE SCREW WAS CUT WITH A WIRE DRIVER UNTIL IT WAS FLUSH AGAINST THE BONE. THIS WAS DISCOVERED DURING A HAMMERTOE CORRECTION AND THE CASE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23698053 ↗
• MalfunctionSep 15, 2025Break; Break

  ON 08/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-37 HEX DRIVER BROKE OFF INSIDE THE PATIENT. THE FRAGMENT WAS ABLE TO BE RETRIEVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051984 ↗
• MalfunctionAug 8, 2025Break; Break

  ON 07/22/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-06983950 THAT AN AR-8737-37 DRIVER SHAFT, AND (3) AR-8741-42 4.0 MM BEVELED FT DRIVERS BROKE. THIS OCCURRED DURING A MIS BUNION PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22750706 ↗
• MalfunctionJul 17, 2025Break; Break

  ON 06/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-37 1.5MM HEX DRIVER BROKE OFF IN 2.5 COMPRESSION FT SCREW. THIS WAS DISCOVERED DURING THE CASE AND THE BROKEN PIECE WAS NOT RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530385 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A MICA SURGERY THE SCREW DRIVER BROKE WHILE INSERTING THE SCREW. THE BROKEN OFF PIECE HAS BEEN 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 21664766 ↗
• MalfunctionSep 16, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06650433 THAT AN AR-8737-37 DRIVER SHAFT BROKE (SEE PHOTO ATTACHMENT). NO PIECES BROKE INSIDE THE PATIENT AND THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING AN ELBOW FRACTURE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20223336 ↗
• MalfunctionSep 13, 2024Break; Break

  ON 008/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8737-37 DRIVER SHAFTS WERE COMPROMISED. THIS OCCURRED DURING A CASE ON (B)(6) 2024 WHEN IMPLANTING THE TIP OF THE FIRST SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW DURING IMPLANTATION. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN DRIVER FROM THE SCREW HEAD AND FINISHED IMPLANTATION WITH A BACKUP DRIVER. THE SURGEON NOTED THE SECOND DRIVER SEEMED TO ALSO BE STRIPPED AND CLOSE TO BREAKING.

  Patient problems: Insufficient Information

  MAUDE report 20216630 ↗
• MalfunctionJul 5, 2024Break; Break

  ON 6/10/2024 AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS (B)(4) REPORTED THAT AN AR-8737-37 DRIVER SHAFT BROKE DURING USE. THE BROKEN PART WAS FOUND AFTER SCREW INSERTION AND WAS BURIED IN THE SCREW HEAD. THE PIECE WAS REMOVED WITH A FORCEPS AND THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A PROCEDURE (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/17/2024: THERE WAS NO CASE DELAY. THIS WAS DISCOVERED DURING A HALLUX VALGUS PROCEDURE. THE CASE WAS COMPLETED BY REMOVING DEBRIS FROM THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19679937 ↗
• MalfunctionApr 26, 2024Break; Break

  ON 04/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-37 DRIVER SHAFT BROKE. THIS OCCURRED DURING AN OATS PROCEDURE WHERE THE BROKEN DRIVE WAS REMOVED AND ANOTHER DRIVER WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19190842 ↗
• MalfunctionApr 26, 2024Break; Break

  ON 04/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06530912 THAT AN AR-8737-37 DRIVER SHAFT BROKE. THIS OCCURRED DURING AN OATS PROCEDURE ON (B)(6) 2024 WHERE THEY TOOK OUT BROKEN DRIVER AND USED ANOTHER DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 19190525 ↗
• MalfunctionMar 28, 2024Break; Break

  ON (B)(6) 2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8737-37 DRIVER SHAFT, 1.5 MM HEX, CANNULATED TIP BROKE OFF IN THE PATIENT'S THIRD TOE. THE MICRO SCREWDRIVER COULD NOT BE RETRIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18996079 ↗
• MalfunctionFeb 9, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS (B)(4) THAT AN AR-8737-37 BONE REDUCTION FORCEPS DRIVER TIP BROKE INSIDE THE SCREW. THIS OCCURRED DURING A PROCEDURE WHILE DRILLING THE TALUS TO THE CORRECT DEPTH OF THE SCREW. WHILE FINISHING THE INSERTION, THE DRIVER TIP BROKE INSIDE THE SCREW. THE FRAGMENT WAS RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 18676149 ↗
• MalfunctionOct 26, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8737-37 HEX DRIVER SHAFT BROKE WHEN IMPLANTING A 2.5MM MICRO SCREW. THE BROKEN DRIVER TIP WAS REMOVED FROM THE SCREW WITHOUT STRIPPING THE SCREW HEAD. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 7/17/2023: THIS WAS DISCOVERED DURING A BUNION CORRECTION PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY AFTER REMOVING THE BROKEN DRIVER TIP AND THE SCREW WAS IMPLANTED AS IT DID NOT SUFFER ANY DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011703 ↗
• InjurySep 7, 2023Break; Break

  ON 8/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-37 DRIVER SHAFT, 1.5 MM HEX, CANNULATED, HAD AN ISSUE. THE DRIVER TIP BROKE IN THE COMP FT SCREW AND WOULD NOT COME OUT. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME ON (B)(6) 2023. NO CASE/PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED. ON 8/25/2023, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THIS OCCURRED DURING USE IN A DIP FUSION PROCEDURE. THE INSTRUMENT WAS NOT USED WITH POWER. THE BROKEN DRIVER TIP WAS REMOVED FROM A MICRO COMP FT SCREW 32MM, BUT THE SCREW WAS DAMAGED AND COULD NOT BE INSERTED FULLY. IT ALSO COULD NOT BE REMOVED BY THE SURGEON, SO IT WAS LEFT INSIDE THE PATIENT BUT WAS NOT SEATED FULLY FLUSH. THERE WAS NO DEVIATION FROM THE INTENDED PROCEDURE, AND THE PROCEDURE WAS COMPLETED. THIS CAUSED A TWO-HOUR CASE DELAY, AND ADDITIONAL ANESTHESIA HAD TO BE ADMINISTERED TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. ON 8/29/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THE LOT NUMBER FOR THE MICRO 32MM SCREW WAS NOT AVAILABLE. IT COULD NOT BE CONFIRMED IF A SECOND SURGERY WOULD BE NEEDED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17701973 ↗
• MalfunctionAug 31, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-37 DRIVER SHAFT HAD AN ISSUE DURING A FIRST MTP ARTHRODESIS PROCEDURE ON (B)(6) 2023. AFTER THE MTP JOINT WAS PREPPED, THE SURGEON THROUGH IN A .86 K WIRE, AND DRILLED OVER THE WIRE WITH A 2.0 CANNULATED DRILL. THEN THEY PLACED A 2.5X40 COMPRESSION FT SCREW ON POWER WITH THE DEVICE. ONCE THE SCREW WAS INSERTED 3/4 THE LENGTH, THE DRIVER TIP BROKE OFF INSIDE THE HEAD OF THE SCREW. THE WIRE WAS REMOVED, AND A DENTAL PICK WAS USED TO EXTRACT THE BROKEN TIP OF THE DRIVER FROM THE HEAD OF THE SCREW. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THE SCREW WAS INSERTED THE REST OF THE WAY BY HAND WITH A NEW DRIVER. AN X-RAY WAS OBTAINED TO MAKE SURE THERE WERE NO OTHER PIECES LEFT IN THE PATIENT. THE SURGERY FINISHED SUCCESSFULLY AS PLANNED, AND NO HARM WAS DONE TO THE PATIENT. A SECOND SURGERY WILL NOT BE NEEDED. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662507 ↗
• MalfunctionAug 18, 2023Break; Break

  ON 7/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-37 DRIVER SHAFT BROKE WHILE IMPLANTING A 2.5 MICRO SCREW. THE BROKEN PIECE OF THE DRIVER FROM THE INSIDE OF THE SCREW WAS TAKEN OUT WITHOUT HARM TO THE PATIENT AND THE SCREW ITSELF. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573450 ↗
• MalfunctionJul 10, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIP OF AN AR-8737-37 CANNULATED1.5 HEX DRIVER BROKE OFF IN THE SCREW DURING INSERTION. THE SURGEON DECIDED TO LEAVE IT IN AS THE TIP WAS SECURE WITHIN THE ANCHOR AND IMPLANTED SUCCESSFULLY. THIS WAS DISCOVERED DURING AN INTERPHALANGEAL JOINT FUSION PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287075 ↗
• MalfunctionJul 3, 2023Break; Break

  ON 6/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN AR-8737-37 DRIVER SHAFT HAD AN ISSUE. WHILE PUTTING IN AN INTERFRAG SCREW FOR AN MTP FUSION PROCEDURE ON (B)(6) 2023, BOTH DRIVER SHAFTS FOR THE MICRO COMP FT SCREWS SNAPPED. THE SURGEON INSERTED THE SCREW BY HAND AND DID NOT PUT EXCESSIVE TORQUE. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 6/13/2023, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THIS OCCURRED TWICE IN A ROW IN THE SAME CASE. THE DRIVER SHAFTS BROKE INSIDE THE PATIENT, AND ALL FRAGMENTS WERE REMOVED EACH TIME. ADDITIONAL INFORMATION WAS REQUESTED. ON 6/20/2023, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA EMAIL: THE CASE WAS COMPLETED BY PULLING THE K-WIRE OUT AND USING A SOLID DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246302 ↗
• MalfunctionMay 31, 2023Break; Break

  ON 05/08/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-37 HEXALOBE DRIVER BROKE UPON INSERTION OF 2.5MM COMPRESSION SCREWS. THIS WAS DISCOVERED DURING A CASE, DEVICE BROKE DURING USE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17032326 ↗
• MalfunctionMay 18, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 5/24/2023: THIS WAS DISCOVERED DURING A WRIST ARTHROSCOPY WITH ARTHRODESIS OF PSEPHTHROSIS OF THE LEFT SCAPHOID AFTER WRIST FRACTURE. THE BROKEN TIP OF THE DRIVER WAS LEFT INSIDE THE SCREW AND IMPLANTED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16955158 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-37 HEXALOBE DRIVER BROKE UPON INSERTION OF 2.5MM COMPRESSION FT SCREW. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870075 ↗