MAUDE Adverse Event Report: ARTHREX, INC. 2-0 SUTR CUTR,2.75 MM STR SFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	2-0 SUTR CUTR,2.75 MM STR SFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
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 08/18/2025, it was reported by a sales representative via (b)(4) that an ar-11790 suture cutter cutting system broke.The fragment was retrieved with a shaver/suction and grasper.This occurred during use in a knee arthroscopy case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.- one unpackaged ar-11790, batch number 17937, was received for evaluation.- visual inspection noted that the cutting tip was stuck in one position and would not engage with the handle.Additionally, the device had significant signs of wear along its body: discoloration, fading of the laser marks, and material degradation.- functional testing was not performed due to the damage to the device.- the most likely cause of the reported failure is wear and tear damage incurred over repeated usage.- refer to the investigation images.- the complaint allegation is confirmed.

• Brand Name: 2-0 SUTR CUTR,2.75 MM STR SFT
• 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: 22999539
• Report Number: 1220246-2025-03756
• Device Sequence Number: 15832514
• Product Code: MDM
• UDI-Device Identifier: 00888867003576
• UDI-Public: 00888867003576
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 2-0 SUTR CUTR,2.75 MM STR SFT
• Device Catalogue Number: AR-11790
• Device Lot Number: NO LONGER VISIBLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown