MAUDE Adverse Event Report: ARTHREX, INC. MODULAR DRILL, 10­° FULL, 25 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	MODULAR DRILL, 10­° FULL, 25 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via (b)(4) that an ar-9596-1025f modular drill broke.This occurred during a case and caused no issues for the patient.Additional information was provided on 01/23/2025, where the sales representative stated that this event occurred during a reverse procedure on (b)(6) 2025.The device broke while being used.The patient had a fair bone quality.All fragments were able to be retrieved from the patient.There was no delay in the procedure, and no additional anesthesia needed to be administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: MODULAR DRILL, 10­° FULL, 25 MM
• 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: 21356277
• Report Number: 1220246-2025-00378
• Device Sequence Number: 9078586
• Product Code: HWE
• UDI-Device Identifier: 00888867346109
• UDI-Public: 00888867346109
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/18/2025

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: MODULAR DRILL, 10­° FULL, 25 MM
• Device Catalogue Number: AR-9596-1025F
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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