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

Model Number	DRILL SAW SPORTS 400
Medical Device Problem Codes	Defective Component (2292); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the both devices are defective and they wobble.There was no harm for patient, operator or third party.There was no case involvement reported.No further information received.Update, khe, (b)(6) 2024.Receive further information.It was reported that the machine runs irregularly from the saw blade during use.Per complaint reporter there was no harm for patient, operator or third party.Update, khe, (b)(6) 2024.Further information received.The event occurred during a repositioning osteotomy femur.No piece broke off inside the patient.The surgery was finished successfully with the claimed device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed.The manufacturer evaluation revealed the driver is broken off.Ar-400: the driver of the ar-400 is broken.This known issue has already been resolved with an appropriate corrective measure.The driver was reinforced with a ring (assembly 775770, index 00).Ar-400sag: the attachment was disassembled to allow for a more detailed analysis.The cause of the failure of the saw attachment is a broken claw (part 5).

• 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: 20556280
• Report Number: 1220246-2024-08292
• Device Sequence Number: 11554156
• Product Code: HWE
• UDI-Device Identifier: 00888867223318
• UDI-Public: (01)00888867223318(11)240219(10)15211910
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/23/2025

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: 15211910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 08/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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