MAUDE Adverse Event Report: ARTHREX, INC. SAW ATTACHMENT-SAGITTAL; POWERED SURG ORTHOPEDIC INSTR

Model Number	SAW ATTACHMENT-SAGITTAL
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery according to austin/akin the device ar-400sag (sn: (b)(6)) could not be inserted.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.
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 not confirmed.The manufacturer evaluation revealed the drive shaft is defective, but there is no problem found with the tool connection.

• Brand Name: SAW ATTACHMENT-SAGITTAL
• 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: 23743631
• Report Number: 1220246-2025-05450
• Device Sequence Number: 8469527
• Product Code: HWE
• UDI-Device Identifier: 00888867223424
• UDI-Public: (01)00888867223424(11)241010(10)15339064
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 02/11/2026

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: SAW ATTACHMENT-SAGITTAL
• Device Catalogue Number: AR-400SAG
• Device Lot Number: 15339064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown