MAUDE Adverse Event Report: ARTHREX, INC. AVL 4.5MM INFERIOR DRILL, MODULAR; POWERED SURG ORTHOPEDIC INSTR

Model Number	AVL 4.5MM INFERIOR DRILL, MODULAR
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6: the complaint allegation is confirmed.One unpackaged ar-9239ag was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted that all the laser markings are worn off the device.Also, the device shows signs of wear and tear throughout.The most likely cause is attributed to wear and tear due to repeated use of the device.

• Brand Name: AVL 4.5MM INFERIOR DRILL, MODULAR
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24035656
• Report Number: 1220246-2026-00122
• Device Sequence Number: 21100995
• Product Code: HWE
• UDI-Device Identifier: 00888867350489
• UDI-Public: 00888867350489
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVL 4.5MM INFERIOR DRILL, MODULAR
• Device Catalogue Number: AR-9239AG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown