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

Model Number	SAW ATTACHMENT-SAGITTAL
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
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
It was reported that during a conversion open-wedge osteotomy foot surgery the ar-400sag jammed and did not work.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (synthes colibri).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.A most likely cause might be attributed to wear and tear resulting from repeated use.

• 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: 19950773
• Report Number: 1220246-2024-07124
• Device Sequence Number: 12986217
• Product Code: HWE
• UDI-Device Identifier: 00888867223424
• UDI-Public: 00888867223424
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: SAW ATTACHMENT-SAGITTAL
• Device Catalogue Number: AR-400SAG
• Device Lot Number: 15185889
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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