MAUDE Adverse Event Report: ARTHREX, INC. DRILL SAW SPORTS 400; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL SAW SPORTS 400
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2025
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 07/08/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-400 drillsaw sports 400 system overheated.This occurred during an acl procedure.
Additional Manufacturer Narrative
Additional information: the complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is wear and tear of the device, as the manufacturing date registered is 2023.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: DRILL SAW SPORTS 400
• 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: 22663461
• Report Number: 1220246-2025-03132
• Device Sequence Number: 19758362
• Product Code: HWE
• UDI-Device Identifier: 00888867223318
• UDI-Public: (01)00888867223318(11)230322(10)15070917
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: DRILL SAW SPORTS 400
• Device Catalogue Number: AR-400
• Device Lot Number: 15070917
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown