MAUDE Adverse Event Report: ARTHREX, INC. SCISSOR, 3.4MM , L CURVED STR W/WB; MANUAL INSTR, GENERAL SURGICAL

Model Number	SCISSOR, 3.4MM , L CURVED STR W/WB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
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 07/18/2025, a sales representative reported via (b)(4) that an ar-12160w wishbone¿ scissor serrated jaw snapped off.The issue was discovered during the surgery.Another device was swapped, and the case was completed with no adverse effects to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.- one unpackaged ar-12160w, wishbone¿ scissor, batch 10244516, was received for investigation.- visual inspection noted that the cutting edges had nicks/damage, and the lower cutting blade was cracked.- functional testing noted that the driver functions as intended.The most likely cause of the reported failure is user error, which can be attributed to prying/leveraging the device with excessive force during use.- refer to the investigation photos.- complaint allegation is confirmed.

• Brand Name: SCISSOR, 3.4MM , L CURVED STR W/WB
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 22736454
• Report Number: 1220246-2025-03298
• Device Sequence Number: 7125567
• Product Code: MDM
• UDI-Device Identifier: 00888867005273
• UDI-Public: (01)00888867005273(11)181009(10)10244516
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: SCISSOR, 3.4MM , L CURVED STR W/WB
• Device Catalogue Number: AR-12160W
• Device Lot Number: 10244516
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown