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

Model Number	DRILLSAW HIGHSPEED 200
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
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 07/18/2025, it was reported by a sales representative via (b)(4) that an ar-200m motor of ar-200 is warm to the touch when running.Discovered during a case with no patient effect.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 details from the field, arthrex was able to determine the most likely cause.The reported failure is most likely due to moisture intrusion.Dfu-0225-6r0_fmt_en-us - drillsaw highspeed 200 user¿s guide the precaution! symbol identifies methods and procedures that must be followed to avoid damaging the device or causing it to malfunction.9.Never use liquid to clean the accessory device connector contacts.Remove dust regularly using dry compressed air.12.Never allow the console receptacles to have any contact with liquids.If there is dust or moisture on the receptacles, remove using dry compressed air.Only dry connectors should be plugged into the console.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: 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: 22738097
• Report Number: 1220246-2025-03311
• Device Sequence Number: 7218210
• Product Code: HWE
• UDI-Device Identifier: 00888867184169
• UDI-Public: (01)00888867184169(11)230202(10)15051931
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: DRILLSAW HIGHSPEED 200
• Device Catalogue Number: AR-200
• Device Lot Number: 15051931
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown