Arthrex® AR-8967DRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888867056718), received between Feb 23, 2017 and Feb 25, 2025 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE TIP OF THE SCREWDRIVER BROKE WHILE INSERTING THE SCREW. 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 21460791 ↗
• MalfunctionNov 7, 2024Break; Break

  ON 10/25/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8967D DRIVER BROKE. THIS OCCURRED DURING A SURGERY WHERE NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE ENDED NORMALLY, USING ANOTHER KEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632168 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION PLATING SURGERY THE SCREW DRIVER TIP BROKE OFF. THE BROKEN PIECE WAS RETRIEVED OUT OF 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 20599781 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANKLE FUSION SURGERY THE DRIVER BROKE. ALL 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. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749978 ↗
• MalfunctionMay 28, 2024Break; Break

  IT WAS REPORTED ON 09/27/2021 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8967D SCREWDRIVERS BROKE WHILE INSERTING A 6.7 SHORT THREAD SCREW. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404706 ↗
• MalfunctionMay 28, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THR 3.5MM HEX DRIVER BROKE DURING USE. 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 19403412 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE ADVANCING A 6.7MM CANNULATED SCREW A SMALL PIECE AT THE TIP OF THE HEX DRIVER, AR-8967D, BROKE OFF. THE SURGEON REMOVED ALL BROKEN PIECES FROM THE PATIENT. NOTHING WAS LEFT IN THE PATIENT. IT WAS THE HOSPITAL'S POLICY TO TEMPORARILY KEEP THE BROKEN DRIVER FOR DOCUMENTATION AND THE REP UNSURE IF/WHEN HE CAN GET IT BACK. THERE WAS NO ILL EFFECTS AND THE CASE WAS COMPLETED SUCCESSFULLY BY OPENING A SEPARATE SCREW DRIVER. ADDITIONAL INFORMATION PROVIDED 1/18/2021: NO ADDITIONAL INCISION NEEDED. THE SURGEON WAS ABLE TO RETRIEVE IT WITH A RONGEUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319806 ↗
• MalfunctionMay 15, 2024Break; Break

  ON (B)(6) 2024 IT WAS REPORTED BY FIELD STAFF VIA EMAIL THAT AN AR-8967D DRV,3.5MM HEX,CANN (MINI HUDSON) SNAPPED AT THE TIP DURING USE. THIS OCCURRED ON (B)(6) 2024 IN (B)(6) HOSPITAL DURING A SUB TALAR FUSION. THE CASE WAS COMPLETED SUCCESSFULLY VIA THE USE OF ANOTHER DRIVER. THERE WAS PATIENT/CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19319793 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE SCREWDRIVER TIP BROKE WHEN INSERTING THE SCREW. 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 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 19260903 ↗
• MalfunctionJan 5, 2024Material Fragmentation; Material Fragmentation

  ON 12/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8967D DRIVER BROKE DURING USE. THE CASE WAS COMPLETED BY RETRIEVING ALL FRAGMENTS AND USING A DIFFERENT DRIVER TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A HARDWARE REMOVAL PROCEDURE OF A DFO PLATE, WITH NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/28/2023: THE DATE OF THE PROCEDURE WAS ON (B)(6) 2023. THERE WAS NO DELAY IN THE CASE DUE TO HAVING TWO DRIVERS IN THE TRAY. THE PATIENT HAD NO ADVERSE EFFECTS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 1/5/2023: IT WAS CONFIRMED ON 1/5/2023 VIA E-MAIL BY THE SALES REPRESENTATIVE FOR CASE #: (B)(4) ON SEMS TICKET (B)(4) FOR THE COMPLAINT DEVICE AR-8967D DRIVER/BATCH: 011725 THAT BROKE DURING A HARDWARE REMOVAL PROCEDURE OF A DFO PLATE ON (B)(6) 2023 WAS NOT A REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18457114 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT DURING A CALCANEAL OSTEOTOMY THE HEX SCREWDRIVER BROKEN WHEN SURGEON TURNING IN 6.7 LPS SCREW. THE BROKEN PARTS REMOVED UNDER X RAY GUIDANCE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 24-MAY-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON INITIALLY USED THE AR-1416 AND AR-8967D ON POWER TO INSERT THE SCREWS. HE THEN REVERTED TO FINAL TIGHTENING USING AR-8967D AND AR-1999.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152354 ↗
• MalfunctionAug 1, 2022Break

  IT WAS REPORTED THAT DURING A FLATFOOT RECONSTRUCTION (CALCANEAL OSTEOTOMY & INTERNAL BRACE) SURGERY WHILST USING THE DEVICE, THE END OF THE 3.5 HEX DRIVER THAT IS IN CONTACT WITH THE SCREW SNAPPED OFF WHEN THE SURGEON WAS INSERTING THE SCREW INTO THE PATIENT. THE SURGEON RETRIEVED THE BROKEN PART AND FINISHED THE CASE. PROPER TECHNIQUE WAS USED. NO SURGEON ERROR OR MISUSE OF THE INSTRUMENT. 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 15137918 ↗
• MalfunctionApr 11, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8967D DRIVER BROKE. THIS OCCURRED DURING A CASE AND BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 14075140 ↗
• MalfunctionMar 14, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8967D HEX DRIVER AND THE HEAD OF THE SCREW BROKE DURING USE. SURGEON USED A PRODUCT FROM ANOTHER MANUFACTURERS TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 13758007 ↗
• MalfunctionSep 28, 2021Break

  ON 09/07/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT THE AR-8967D DRIVE TIP BROKE WHILE INSERTING A SCREW. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED WITH A NEW AR-8967D. ADDITIONAL INFORMATION PROVIDED 09/08/2021: THE TIP OF DEVICE BROKE OFF COMPLETELY. THE FRAGMENT WAS REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED BY USING A NEW AR-8967D.

  Patient problems: Insufficient Information

  MAUDE report 12540085 ↗
• MalfunctionAug 17, 2021Break

  IT WAS REPORTED THAT DURING CALCANEUS MEDIALISIERUNC SURGERY THE TIP DID BREAK OFF WHILE SCREWING IN THE SCREW. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12332955 ↗
• MalfunctionMay 18, 2021Break

  IT WAS REPORTED THAT A CALCANEUS MEDIALISATION WAS PERFORMED WITH A LPS 6.7 SCREW WAS USED. DURING SCREWING IN THE SCREW THE SCREW DRIVER BROKE OFF COMPLETELY. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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: Insufficient Information

  MAUDE report 11841408 ↗
• InjuryDec 26, 2019Break

  IT WAS REPORTED THAT DURING A CASE, THE TIP OF THE HEX DRIVER, AR-8967D, BROKE WHILE THE SURGEON WAS INSERTING THE SCREW. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED 12/11/19: PROCEDURE BEING PERFORMED WAS AN ANKLE FUSION. EACH PIECE OF THE DRIVER WAS REMOVED WITH ADSON FORCEPS, A NEEDLE DRIVER AND ALSO A GRASPER TO GET THE INDIVIDUAL PIECES OUT WHILE UTILIZING FLUOROSCOPY. THE INCISION WAS EXTENDED 1MM. THE CASE WAS COMPLETED BY USING THE ADDITIONAL 3.5MM HEX DRIVER FROM THE 4.5/6.7 TRAY. THE FRAGMENTS WILL NOT BE RETURNED WITH THE REST OF THE DRIVER, THE ACCOUNT HAD CONCERNS WASHING THE SMALL FRAGMENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519516 ↗
• InjuryJun 14, 2018Break

  IT WAS REPORTED THAT DURING A DISTAL FEMUR FX-RLE PROCEDURE, UPON MEETING RESISTANCE FROM TWO 6.3 HERBERT SCREWS IMPLANTED FIRST, THE 3.5 HEX DRIVER BROKE UPON INITIAL INSERTION OF A 6.7 MM FULLY THREADED CANNULATED SCREW, AR-8967-60FT. THE TIP BROKE INTO SEVERAL FRAGMENTS, WHICH WERE ALL RETRIEVED BY EXTENDING THE INCISION SITE. THE 6.7 FULLY THREADED SCREW WAS REMOVED WITH BACKUP 3.5 HEX DRIVER. PATIENT IS A MALE, (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 7600194 ↗
• InjuryJan 10, 2018Break; Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANKLE FUSION/RIGHT ANKLE PROCEDURE, THE TIP OF THE 3.5MM HEX DRIVER BROKE OFF WHILE THE SURGEON WAS DRIVING THE SCREW. THE SURGEON WAS ABLE TO REMOVE THE MAJORITY OF THE FRAGMENTS, HOWEVER, A SMALL PIECE OF THE DRIVER TIP REMAINED IN THE PATIENT. A SECOND DRIVER FROM THE TRAY WAS USED TO FINISH IMPLANTING SCREW SUCCESSFULLY. FOLLOW-UP INVESTIGATION: AN X-RAY WAS TAKEN AND CONFIRM THE PRESENCE OF THE FRAGMENT IN THE PATIENT'S POSTERIOR LATERAL ANKLE, HOWEVER, THE X-RAY IS NOT AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7178416 ↗
• InjuryFeb 23, 2017Break; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRIPLE ARTHRODESIS PROCEDURE ON (B)(6) 2016. AROUND (B)(6) 2016, THE PATIENT NOTICED DRAINAGE FROM A SMALL OPENING IN HIS LEFT LATERAL FOOT INCISION. THE PATIENT TESTED POSITIVE FOR PREVOTELLA DISIENS BETA LACTAMASE AND TESTED NEGATIVE FOR FINEGOLDIA MAGNA BETA LACTAMASE AND GEMELLA MORBILLORUM BETA LACTAMASE. THE PATIENT WAS PRESCRIBED 500 MG OF KEFLEX TWICE A DAY FOR 7 DAYS. SURGEON HAD PLANNED A REVISION TO REMOVE ONLY THE TWO 4.5 MM SCREWS THAT WERE IN CLOSEST PROXIMITY TO THE INFECTED AREA HOWEVER, THE PATIENT'S INFECTION CONTROL DOCTOR WANTED FOR ALL THE HARDWARE TO BE REMOVED. REVISION TOOK PLACE (B)(6) 2017. WHILE REMOVING THE HARDWARE FROM THE (B)(6) 2016 TRIPLE ARTHRODESIS, THE TIP OF THE 3.5 CANNULATED HEX DRIVER, AR-8967D, LOT UNKNOWN, ((B)(4)) BROKE INTO MULTIPLE PIECES. THE SURGEON HAD STARTED THE REMOVAL OF THE 6.7 MM SCREW WITH THE DRIVER ON A RATCHETING HANDLE, AND ON HIS FIRST ATTEMPT OF USING POWER, THE HEX DRIVER BROKE. ALL PIECES WERE REMOVED AND ACCOUNTED FOR EXCEPT FOR ONE, IT WAS NOT FOUND IN THE STERILE FIELD AND THE SURGEON COULD NOT SEE ANYTHING LARGE ENOUGH ON X-RAY TO GO AFTER BEFORE CLOSING. THE SCRUB TECH H

  Patient problems: Unspecified Infection

  MAUDE report 6352223 ↗