MAUDE Adverse Event Report: ARTHREX, INC. DOUBLECUT, 4.0MM X 13CM; SAW BLADE

Model Number	DOUBLECUT, 4.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
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
On 01/22/2025, it was reported by a facility representative via (b)(4) that two boxes of (qty.5) ar-8400dc 4mm x 13cm doublecuts have extra pieces of metal at the end of tip.They were involved in a case and the patient was not harmed.They were able to remove excess metals from inside the patient.All fragments were retrieved.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information received on 2/26/2025 by the sales rep: follow-up was conducted, and it was reported that only two individual devices had extra pieces of metal at the end of tip ar-8400dc 4mm x 13cm doublecuts, not two boxes.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint devices were not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including side loading, misaligned insertion, and/or prying or levering the device during use.The complaint allegation could not be confirmed, as the devices were not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: DOUBLECUT, 4.0MM X 13CM
• 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: 21349407
• Report Number: 1220246-2025-00354
• Device Sequence Number: 15374816
• Product Code: GFA
• UDI-Device Identifier: 00888867043565
• UDI-Public: (01)00888867043565(11)240725(17)290630(10)15293118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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: DOUBLECUT, 4.0MM X 13CM
• Device Catalogue Number: AR-8400DC
• Device Lot Number: 15293118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/26/2025; 09/02/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/17/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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