Arthrex® AR-9239Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867059528), received between Mar 8, 2021 and Sep 15, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY A PART OF THE DRILL 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 23051904 ↗
• MalfunctionMay 22, 2024Damaged Thread; Damaged Thread

  ON 08/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-9239 4.5MM QUICK RELEASE DRILL HAD AN ISSUE. DURING A TOTAL SHOULDER REPLACEMENT ON 08/22/2022, IT TOTALLY STRIPPED THE DRILL - NO FLUTES LEFT UPON NORMAL USE. THE CASE WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENCE, THERE WAS NO HARM AND NO PIECE BROKE OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370156 ↗
• MalfunctionMay 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT WHILE USING THE AVL REAMERS, SOMEHOW THE REAMER SHAFT GOT COLD WELDED TO THE ANGLED REAMER SLEEVE. SURGEON WAS UNABLE TO UNABLE TO COMPLETE THE AUGMENT AND SWITCHED TO A STANDARD VL. ALSO, THE 4.5 DRILL GOT STUCK IN SMALL DRILL GUIDE. THIS WAS DISCOVERED DURING A TSA PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19369606 ↗
• MalfunctionMay 16, 2024Dull, Blunt; Dull, Blunt

  ON 9/30/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9239 QUICK RELEASE DRILL IS DULL. THIS WAS DISCOVERED DURING A PROCEDURE, NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332968 ↗
• MalfunctionMay 15, 2024Dull, Blunt; Dull, Blunt

  ON 04/18/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE AR-9239 DRILL BIT IS DULL AND HAS A METAL RING SPUR. THIS WAS DISCOVERED DURING USE IN A ECLIPSE TSA ON (B)(6) 2022. THE CASE WAS COMPLETED USING THE SAME DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19318421 ↗
• MalfunctionMay 23, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9239 DRILL BIT BROKE IN THE DRILL GUIDE. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE PATIENT. PER FACILITY: "AR-9239 4.5 DRILL TIP BROKE OFF IN THE VAULTLOCK GUIDE AR-9231-04PP. THE PIECE THAT BROKE OFF WAS RETRIEVED FROM THE PATIENT BUT WAS NOT RETAINED FOLLOWING THE CASE. THE MAJORITY OF THE DRILL WAS RETAINED AND CAN BE SENT IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469582 ↗
• MalfunctionDec 21, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9239 QUICK RELEASE DRILL BROKE. THIS WAS DISCOVERED DURING AN ECLIPSE PROCEDURE ON (B)(6) 2021. AFTER THE SURGEON HAD COMPLETED THE CANAL, THE DRILL BROKE INSIDE THE PATIENT. ALL BROKEN FRAGMENTS WERE RETRIEVED AND CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 13054638 ↗
• MalfunctionMar 8, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE AR-9239 BROKE WHEN DRILLING THE GLENOID, FOR A TOTAL SHOULDER CASE. THE TIP WAS RETRIEVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11437186 ↗