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Arthrex® AR-9239AGRecalls & reported problems

Arthrex, Inc. · AVL 4.5MM INFERIOR DRILL, MODULAR · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867350489), received between Dec 27, 2022 and Jan 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Dull, Blunt1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 12, 2026Dull, Blunt

    ON 22-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9239AG 4.5 MM INFERIOR DRILL WAS DEEMED TOO DULL. THIS WAS DISCOVERED DURING AN ARTHROPLASTY PROCEDURE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24035656 ↗
  • MalfunctionAug 4, 2023Break; Break

    ON 7/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9239AG INFERIOR DRILL WAS BROKEN, NO ADDITIONAL INFORMATION WAS PROVIDED. NO CASE INVOLVEMENT. ON 7/21/2023, THE SALES REPRESENTATIVE STATED VIA EMAIL THAT THE DEVICE HAD BEEN DISCARDED BY THE TECHNICIAN DURING THE CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 7/21/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A RIGHT TOTAL SHOULDER ARTHROPLASTY PROCEDURE. THE INSTRUMENT BROKE WHEN DRILLING THE INFERIOR HOLE ON THE GLENOID FOR THE AUGMENTED VAULTLOCK IMPLANT. ALL FRAGMENTS WERE RETRIEVED, AND THEY USED A DRILL FROM ANOTHER TRAY. THERE WERE NO ADVERSE REACTIONS OR EVENTS FROM THE PATIENT. THE CASE WAS COMPLETED AS NORMAL BUT WITH THE BACKUP DRILL BIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17458235 ↗
  • MalfunctionDec 27, 2022Break

    ON 12/08/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9239AG INFERIOR DRILL, AND A AR-9231-VL-01 DRILL GUIDE DIDN'T HOLD UP UNDER THE TORQUE IT RECEIVED, AND BOTH DEVICES BROKE. THIS OCCURRED DURING A CASE, ANOTHER TRAY WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16052032 ↗

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Sources and updates

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