MAUDE Adverse Event Report: ARTHREX, INC. SAWBLD,300,SAGITTAL W/STOP; SAW BLADE

Model Number	SAWBLD,300,SAGITTAL W/STOP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/02/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-400 drillsaw sports 400 system detached.This occurred during a case.There was no additional information was provided, and additional information has been requested.Additional information was provided on 10/07/2024 where it was stated that this event occurred during a cruciate ligament procedure when the device broke at the time of being actuated.An ar-300-406s saw blade was being used.All fragments were retrieved from the patient.A cinsel and hammer were used to complete the case.There was no additional anesthesia administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the attachment during use.

• Brand Name: SAWBLD,300,SAGITTAL W/STOP
• Common Device Name: SAW BLADE
• 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: 20698138
• Report Number: 1220246-2024-08551
• Device Sequence Number: 6471312
• Product Code: GFA
• UDI-Device Identifier: 00888867028449
• UDI-Public: 00888867028449
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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): 06/11/2025

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: SAWBLD,300,SAGITTAL W/STOP
• Device Catalogue Number: AR-300-406S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown