MAUDE Adverse Event Report: ARTHREX, INC. AVL 6MM SUPERIOR DRILL, MODULAR; POWERED SURG ORTHOPEDIC INSTR

Model Number	AVL 6MM SUPERIOR DRILL, MODULAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-jan-2026, it was reported by a sales representative via (b)(4) that an ar-9221ag and an ar-9215-1-03 handle and bench drill were broken.No further information was provided.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: AVL 6MM SUPERIOR 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: 24080503
• Report Number: 1220246-2026-00219
• Device Sequence Number: 9776556
• Product Code: HWE
• UDI-Device Identifier: 00888867350472
• UDI-Public: 00888867350472
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/18/2026

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 6MM SUPERIOR DRILL, MODULAR
• Device Catalogue Number: AR-9221AG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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