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
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 ↗
Other INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices
- NA 511.701Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2,164 reports
- SmartLife 7126-120-000Stryker Corporation · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1,065 reports
- NA 05.001.224Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT987 reports
- NA 05.001.206Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT632 reports
- NA 532.021Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT521 reports
- NA 2570-04-501Depuy (Ireland) · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT500 reports
- NA 532.110Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT433 reports
- NA 05.001.223Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT397 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page