MAUDE Adverse Event Report: ARTHREX, INC. DRILLSAW HIGHSPEED 200; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILLSAW HIGHSPEED 200
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
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 3-mar-2026, it was reported by a sales representative via sems-07255111 that an ar-200 of ar-200m motor cable was getting hot to the touch and smoking.Noticed during a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Vendor evaluation confirmed the complaint.Please refer to attached evaluation from vendor.

• Brand Name: DRILLSAW HIGHSPEED 200
• 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: 24668347
• Report Number: 1220246-2026-01606
• Device Sequence Number: 13072485
• Product Code: HWE
• UDI-Device Identifier: 00888867184169
• UDI-Public: (01)00888867184169(11)240814(10)15302514
• 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): 04/16/2026

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: DRILLSAW HIGHSPEED 200
• Device Catalogue Number: AR-200
• Device Lot Number: 15302514
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown