Arthrex® AR-4009SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867031272), received between Jun 19, 2019 and Sep 8, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667625 ↗
• MalfunctionDec 31, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-4009S, OSTEOCHONDRAL FLAP REPAIR SINGLE SHOT INSTRUMENTS, THE DRILL BIT BROKE WITHIN DRILL SLEEVE. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 WHEN DRILLING FOR 3RD DART. EVERYTHING WAS KEPT IN LINE. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THIS WAS DETECTED DURING AN OCD FIXATION PROCEDURE ON (B)(6) 2025 WHEN DRILLING FOR 3RD DART. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE BROKEN DRILL BIT WAS REMOVED USING THE WIRE DRIVER AND A NEW DRILL BIT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 23935257 ↗
• MalfunctionDec 26, 2025Break; Break

  ON (B)(6) 2025, A DISTRIBUTOR REPORTED VIA (B)(4) THAT (QTY. 2) AR-4009S SINGLE-SHOT INSTRUMENTS WERE REQUESTED TO BE REMOVED FROM CONSIGNMENT DURING AN EHILE ORIF OF OCD. NO PATIENT WAS AFFECTED. ON 15-DEC-2025 ADDITIONAL INFORMATION WAS RECEIVED. THE REP ADVISED THAT THE DRILL BROKE TWICE WHILE DOING AN OCD REPAIR. THEY HAD TO OPEN A SECOND SINGLE-SHOT DISPOSABLE, BUT THE DRILL BROKE AGAIN SO THEY OPENED A MULTI-SHOT GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895759 ↗
• MalfunctionDec 26, 2025Break; Break

  ON (B)(6) 2025, A DISTRIBUTOR REPORTED VIA (B)(4) THAT (QTY. 2) AR-4009S SINGLE-SHOT INSTRUMENTS WERE REQUESTED TO BE REMOVED FROM CONSIGNMENT DURING AN EHILE ORIF OF OCD. NO PATIENT WAS AFFECTED. ON 15-DEC-2025 ADDITIONAL INFORMATION WAS RECEIVED. THE REP ADVISED THAT THE DRILL BROKE TWICE WHILE DOING AN OCD REPAIR. THEY HAD TO OPEN A SECOND SINGLE-SHOT DISPOSABLE, BUT THE DRILL BROKE AGAIN SO THEY OPENED A MULTI-SHOT GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895698 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DRILL BIT BROKE DURING DRILLING. 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 21898652 ↗
• MalfunctionApr 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE IMPLANT FELL OUT OF THE CARTILAGE AFTER IT WAS IMPLANTED. 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 21766520 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED THAT THE THICKER END OF THE DISPOSABLE DRILL, WHICH IS CLAMPED IN THE JACOB'S CHUCK, IS BROKEN OFF ON TWO DEVICES. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 21-AUG-2023: IT WAS CONFIRMED THAT IT IS UNKNOWN IF THE DEVICE BROKE DURING A SURGERY, BUT THE BREAKAGE POINT WOULD HAVE BEEN OUTSIDE OF THE PATIENT, AS THE BREAKAGE WAS AT THE LEVEL OF THE MACHINE'S JACOB'S CHUCK. UPDATE AVOE 21-AUG-2023: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A CHONDRAL DART CARTILAGE FLAKE REFIXATION SURGERY WHEN DRILLING WITH THE DEVICES. 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 17731374 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A CHONDRAL DART SURGERY AN ATTEMPT WAS MADE TO FIX A FLAKE FRACTURE WITH THREE DARTS. ALL THREE DARTS BROKE OFF DURING INSERTION, ALTHOUGH THE PROCEDURE WAS EXACTLY AS DESCRIBED IN THE OPERATION INSTRUCTION. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE FLAKE FRACTURE WAS FIXED SUCCESSFULLY WITH 1.5MM SCREWS BY ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931254 ↗
• MalfunctionJul 11, 2022Break

  IT WAS REPORTED THAT DURING AN OCD LESION OF LATERAL FEMORAL CHONDYLE THE DRILLS BROKE OFF. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. ACCORDING TO THE SURGEON 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: Foreign Body In Patient

  MAUDE report 14978280 ↗
• InjuryJun 19, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OSTEOCHONDRAL REPAIR PROCEDURE, THE SINGLE SHOT SPEAR AND DRILL WAS USED TO INSERT THE FIRST CHONDRAL DART SUCCESSFULLY. A SECOND LOCATION WAS CHOSEN AND THE SINGLE SHOT SPEAR AND DRILL WERE USED. WHEN THE DRILL COLLAR CONTACTED THE BACK OF THE SPEAR, THE COLLAR SHEARED OFF THE DRILL SHAFT. THE PROCEDURE THEN HAD TO BE CONVERTED FROM AN ARTHROSCOPY TO ARTHROTOMY. THE INCISION WAS EXTENDED AND THE AFFECTED CARTILAGE WAS REMOVED AND CHONDRAL DRILLING OF THE DEFECT CARRIED OUT.

  Patient problems: Tissue Damage

  MAUDE report 8711853 ↗