MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE FIBERLINK 1.3MM WH/BL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	SUTURETAPE FIBERLINK 1.3MM WH/BL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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 04/01/2025, it was reported by an arthrex employee via (b)(6) that an ar-12990n scorpion needle and an ar-7535 experienced an issue.When the needle was installed to the scorpion and tried to thread tape, the handle was too stiff to grip.Upon checking, the needle had broken off in the shaft.This was discovered during the case and the case was completed using another device with no patient harm.
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 of the reported failure can be attributed to user error of the concomitant device due to excessive force being used during firing of the needle thus, breaking the needle and causing a blockage within the shaft.

• Brand Name: SUTURETAPE FIBERLINK 1.3MM WH/BL
• 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: 21866353
• Report Number: 1220246-2025-01576
• Device Sequence Number: 7898197
• Product Code: GAT
• UDI-Device Identifier: 00888867288669
• UDI-Public: (01)00888867288669(11)240311(17)290228(10)15186121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171296
• 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): 09/24/2025

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: SUTURETAPE FIBERLINK 1.3MM WH/BL
• Device Catalogue Number: AR-7535
• Device Lot Number: 15186121
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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