MAUDE Adverse Event Report: ARTHREX, INC. 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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 13-feb-2026, it was reported by a distributor via (b)(4) that a qty.7 of ar-7250 fiberwire #0, a qty.5 of ar-7200 fiberwire #2, a qty.1 of ar-7535 fiberlink suture tape were being cut by an ar-12990n scorpion needle during a meniscal root repair procedure.Another ar-12990n needle was opened but continued to cut the sutures.An ar-4068-90 suture lasso was then used as an alternative to try and pass the sutures through tissue but was also unsuccessful.The case was completed successfully with a shoulder scorpion.No patient harm was reported, and no pieces broke off inside the patient.

• Brand Name: 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 24520388
• Report Number: 1220246-2026-01260
• Device Sequence Number: 15579470
• Product Code: GAT
• UDI-Device Identifier: 00888867041851
• UDI-Public: (01)00888867041851(11)221001(17)270930(10)27320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122374
• 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): 06/23/2026

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: 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
• Device Catalogue Number: AR-7250
• Device Lot Number: 27320
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown