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

Model Number	DRILL SAW SPORTS 400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed.The manufacturer evaluation revealed a threaded pin on the coupling is loose, the bearing is worn out and the sleeve on the rotor has come loose.
Event or Problem Description
It was reported that while milling an intramedullary nail, the guide became stuck and, when removed, a small tube came out.Per complaint reporter there was no harm for patient, operator or third party.No further information received.Update avoe 13-nov-2025 it was confirmed that the failure occurred on the 23rd of october during a femur fracture with intramedullary nail surgery.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• 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: 23771342
• Report Number: 1220246-2025-05576
• Device Sequence Number: 13178532
• Product Code: HWE
• UDI-Device Identifier: 00888867223318
• UDI-Public: (01)00888867223318(11)240315(10)15225873
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: DRILL SAW SPORTS 400
• Device Catalogue Number: AR-400
• Device Lot Number: 15225873
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown